| 1 |
NCT03325868 |
Withdrawn |
Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis |
- Adenomyosis
- Heavy Uterine Bleeding
- Dysmenorrhea
|
|
Interventional
|
Phase 4 |
- Vanderbilt University Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bleeding patterns
- Quality of life
- Pain
|
0 |
Female |
18 Years to 51 Years (Adult) |
NCT03325868 |
Ulipristal |
|
February 2018 |
May 2019 |
May 2019 |
October 30, 2017 |
February 8, 2018 |
|
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
|
| 2 |
NCT02213081 |
Unknown † |
Ulipristal for Endometriosis-related Pelvic Pain |
|
|
Interventional
|
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pelvic Pain
- Vaginal bleeding
- Pain with sexual intercourse
- Serum hormone levels
|
25 |
Female |
18 Years to 50 Years (Adult) |
NCT02213081 |
STU00091840 |
|
February 2015 |
June 2017 |
June 2018 |
August 11, 2014 |
September 29, 2016 |
|
- Northwestern University, Prentice Women's Hospital
Chicago, Illinois, United States
|
|
| 3 |
NCT03296098 |
Not yet recruiting |
Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive |
- Contraception
- Healthy Female
|
|
Interventional
|
Phase 2 |
- Health Decisions
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Evaluate the contraceptive efficacy at 6 months based on the calculated Pearl Index for the evaluable for pregnancy population.
- Incidence of treatment emergent adverse events (safety and tolerability) during 6 month use of UPA.
- Changes from baseline in sodium levels (safety and tolerability).
- (and 20 more...)
|
300 |
Female |
18 Years to 35 Years (Adult) |
NCT03296098 |
CCN013B |
CCN013B |
December 2018 |
September 2020 |
December 2020 |
September 28, 2017 |
August 2, 2018 |
|
- Essential Access
Los Angeles, California, United States - University of California, Davis
Sacramento, California, United States - University of California, San Francisco
San Francisco, California, United States - (and 15 more...)
|
|
| 4 |
NCT02361905 |
Unknown † |
Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas |
|
- Drug: ulipristal acetate
- Drug: Leuprolide acetate
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Operative time (minutes)
- Difficulty of leiomyoma enucleation assessed by surgeon on a VAS scale
- Intraoperative blood loss (delta Hb)
- Post-operative evaluation of leiomyomas characteristics
|
42 |
Female |
18 Years to 55 Years (Adult) |
NCT02361905 |
UPA hypoecoic myomas |
|
February 2015 |
September 2017 |
September 2017 |
February 12, 2015 |
November 18, 2016 |
|
- Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, Italy
|
|
| 5 |
NCT02517463 |
Completed
Has Results |
Ulipristal Emergency Contraception Used Before or After Ovulation |
|
|
Observational
|
|
- The University of Hong Kong
- The Family Planning Association of Hong Kong
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Pregnancies Prevented (PPP)
- Failure Rate
- Change in the Length of the Index Menstrual Cycle From Baseline
|
700 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02517463 |
UW10-392 |
|
May 2011 |
April 2014 |
April 2014 |
August 7, 2015 |
July 30, 2018 |
July 30, 2018 |
|
|
| 6 |
NCT02587000 |
Unknown † |
Adenomyosis and Ulipristal Acetate |
|
- Drug: Ulipristal acetate
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Assistance Publique - Hôpitaux de Paris
- Gedeon Richter Ltd.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percentage of patients with a control uterine bleeding estimated by a score of Pictorial Blood-loss Assessment Chart (PABC) < 75 of 28 days to the discontinuation of the study (S13)
- Evolution of the PBAC score over 28 days compared to pre-treatment score (J1)
- Percentage of patients with uterine bleeding control estimated by a score of PBAC < 75 on 28 days
- (and 12 more...)
|
48 |
Female |
30 Years to 50 Years (Adult) |
NCT02587000 |
P141201
2014-004403-75 |
FRA-IIT-UPA |
May 2015 |
December 2017 |
December 2017 |
October 27, 2015 |
September 12, 2017 |
|
- AP-HP, Bicêtre Hospital
Le Kremlin Bicêtre, France
|
|
| 7 |
NCT02922127 |
Recruiting |
Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation |
|
- Drug: Ulipristal Acetate
- Drug: Combined Oral Contraceptive Pill
|
Interventional
|
Phase 1 |
- Columbia University
- Weill Medical College of Cornell University
- Memorial Sloan Kettering Cancer Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Change in breast epithelial cell proliferation rate
- Change in breast epithelial cell proliferation rate in the UPA group compared to the change in the COC group
- Proportion of subjects using UPA who experience a categorical decrease in breast background parenchymal enhancement (BPE)
- Proportion of subjects experiencing a categorical decrease in breast BPE in the UPA group compared to the change in the COC group
|
45 |
Female |
18 Years to 39 Years (Adult) |
NCT02922127 |
AAAQ8498 |
|
December 16, 2016 |
June 2020 |
June 2020 |
October 4, 2016 |
November 8, 2017 |
|
- Columbia University Medical Center
New York, New York, United States - Weill Cornell Medical Center
New York, New York, United States
|
|
| 8 |
NCT02361879 |
Unknown † |
Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma |
|
- Drug: ulipristal acetate
- Drug: Leuprolide acetate
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC)
- Feasibility of myoma hysteroscopic resection (VAS score)
- Operative time
- (and 2 more...)
|
146 |
Female |
18 Years to 55 Years (Adult) |
NCT02361879 |
UPA and hysteroscopy |
|
February 2015 |
September 2017 |
September 2017 |
February 12, 2015 |
November 18, 2016 |
|
- Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, Italy
|
|
| 9 |
NCT03354117 |
Recruiting |
On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility |
|
- Drug: Ulipristal Acetate 30 MG Oral Tablet
|
Interventional
|
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- ovulatory disruption
- luteal hormone levels
- progesterone hormone levels
- maximum follicle diameter
|
20 |
Female |
18 Years to 35 Years (Adult) |
NCT03354117 |
43881 |
|
March 15, 2018 |
July 31, 2019 |
July 31, 2019 |
November 27, 2017 |
June 5, 2018 |
|
- Stanford University
Stanford, California, United States
|
|
| 10 |
NCT02288130 |
Unknown † |
Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy |
|
- Drug: GnRHa
- Drug: Ulipristal
|
Interventional
|
Phase 4 |
- VU University Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Blood loss during surgery
|
100 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02288130 |
2014.421 |
MYOMEX |
December 2014 |
July 2017 |
November 2017 |
November 11, 2014 |
November 3, 2016 |
|
- Flevoziekenhuis
Almere, Netherlands - Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands - Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands - (and 6 more...)
|
|
| 11 |
NCT03342859 |
Recruiting |
Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned |
|
- Drug: Vilaprisan, BAY1002670
- Drug: Ulipristal
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Biomarker for glandular and stromal cell proliferation (Ki-67) in the endometrium of the same patient before treatment and when treated with VPR (vilaprisan) prior to surgery
- Biomarker for myoma cell proliferation (Ki-67) in fibroid tissue of patients not treated with PRM (progesterone receptor modulator )and those who have been treated with VPR prior to surgery
- Biomarkers for apoptotic regulation in the endometrium (BCL-2 (B-cell lymphoma 2), caspase 3) of the same patient before treatment and when treated with VPR prior to surgery
- (and 3 more...)
|
55 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03342859 |
15791
2017-000468-13 |
|
November 16, 2017 |
August 30, 2020 |
October 6, 2020 |
November 17, 2017 |
December 11, 2018 |
|
- Edinburgh Royal Infirmary/ NHS Lothian
Edinburgh, United Kingdom - Forth Valley Royal Hospital
Larbert, United Kingdom
|
|
| 12 |
NCT02357563 |
Unknown † |
Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation |
|
- Drug: ulipristal acetate
- Drug: Leuprolide acetate
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of restored uterine cavity 1 year after enrollment
- Time to pregnancy
- Live birth rate
- Proportion of patients needing surgery after UPA or GnRH-a
|
110 |
Female |
18 Years to 40 Years (Adult) |
NCT02357563 |
UPA myometrial |
|
February 2015 |
September 2017 |
September 2017 |
February 6, 2015 |
November 18, 2016 |
|
- Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, Italy
|
|
| 13 |
NCT03118297 |
Completed
Has Results |
Intervention to End Recurrent Unscheduled Bleeding Trial |
|
- Drug: Ulipristal Acetate
- Drug: Placebo oral capsule
|
Interventional
|
Phase 3 |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries
- Number of Participants With Bleeding Cessation by Day 10
- Participant Satisfaction With Bleeding Pattern at 30 Days
- (and 2 more...)
|
65 |
Female |
18 Years to 45 Years (Adult) |
NCT03118297 |
201612002 |
INTERRUPT |
May 1, 2017 |
January 31, 2018 |
January 31, 2018 |
April 18, 2017 |
August 31, 2018 |
August 31, 2018 |
- Washington University School of Medicine in St. Louis
Saint Louis, Missouri, United States
|
|
| 14 |
NCT02601196 |
Unknown † |
IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure |
- Women With Leiomyoma After at Least One Unsuccessful IVF Treatment
|
|
Interventional
|
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Ongoing pregnancy
- Clinical pregnancy
- Uterus size
- (and 5 more...)
|
20 |
Female |
18 Years to 44 Years (Adult) |
NCT02601196 |
SHEBA-15-2101-EZ-CTIL |
|
September 2016 |
January 2018 |
January 2018 |
November 10, 2015 |
July 12, 2016 |
|
|
|
| 15 |
NCT02451826 |
Active, not recruiting |
A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women |
|
|
Interventional
|
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pharmacodynamic efficacy as measured by the effects of a vaginal ring delivering Ulipristal acetate consistently combined with levonorgestrel administration on the endometrium
- Safety as measured by number of participants with occurrence of adverse events (AEs) and concomitant medication use
|
19 |
Female |
21 Years to 35 Years (Adult) |
NCT02451826 |
674 |
|
May 2015 |
November 1, 2017 |
December 31, 2017 |
May 22, 2015 |
August 15, 2017 |
|
- Profamilia
Santo Domingo, Dominican Republic
|
|
| 16 |
NCT03349190 |
Active, not recruiting |
Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques |
- Infertility, Female
- Fibroid Uterus
|
|
Observational
|
|
- ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
- Gedeon Richter Plc.
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Clinical pregnancy
- Spontaneous pregnancy
- Live birth / miscarriage
- (and 6 more...)
|
127 |
Female |
18 Years to 43 Years (Adult) |
NCT03349190 |
0001 |
NACRE |
December 29, 2017 |
June 30, 2018 |
August 31, 2018 |
November 21, 2017 |
July 18, 2018 |
|
- Chu Angers
Angers, France - Chu Besancon
Besançon, France - Chu Pellegrin
Bordeaux, France - (and 20 more...)
|
|
| 17 |
NCT01391845 |
Unknown † |
Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern |
|
- Drug: ulipristal acetate
- Drug: placebo
|
Interventional
|
Not Applicable |
- Programa de Asistencia Reproductiva de Rosario
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
|
- Changes in Glycodelin-A endometrial expression pattern and Progesterone serum levels in women expose to ulipristal acetate on stimulated ovarian cycles for FIV
- P levels during controlled ovarian stimulation since at least one follicle achieve ≥14mm of diameter
- Serum P levels on two different doses of FSH in a GnRH Antagonist protocol for ovarian stimulation
- Glycodelin-A endometrial expression pattern on two different doses of FSH in a GnRH Antagonist protocol for ovarian stimulation
|
16 |
Female |
21 Years to 35 Years (Adult) |
NCT01391845 |
ist1979 |
|
July 2011 |
March 2012 |
June 2012 |
July 12, 2011 |
July 20, 2011 |
|
- PROAR (Programa de Asistencia Reproductiva de Rosario
Rosario, Santa Fe, Argentina
|
|
| 18 |
NCT02825719 |
Active, not recruiting |
Ulipristal Use in Chinese Population |
|
- Drug: Ulipristal acetate
- Other: Placebo pills
- Drug: Ferrous sulphate
- Drug: Tranexamic Acid
|
Interventional
|
Phase 4 |
- Queen Mary Hospital, Hong Kong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change of uterine bleeding
- Change of haemoglobin level
- Change of fibroid volume
- (and 4 more...)
|
31 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02825719 |
UW 15-022 |
|
December 2, 2015 |
December 2018 |
December 2018 |
July 7, 2016 |
April 6, 2018 |
|
- Department of Obstetrics and Gynaecology, Queen Mary Hospital
Hong Kong, Hong Kong
|
|
| 19 |
NCT03208985 |
Completed |
A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions |
|
- Drug: Use Phase (Ulipristal Acetate, 30 mg)
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Proportion of dosing instances among user population taken within 120 hours (5 days) of most recent episode of unprotected sex.
- Proportion of dosing instances among user population in which no more than one tablet was taken.
- Proportion of female selectors who are not pregnant at the time of selection decision.
|
768 |
Female |
Child, Adult, Older Adult |
NCT03208985 |
151032-001 |
LIBRella |
May 23, 2017 |
June 14, 2018 |
June 14, 2018 |
July 6, 2017 |
August 6, 2018 |
|
- HRA Pharma Investigational Site
Rancho Cucamonga, California, United States - HRA Pharma Investigational Site
Boulder, Colorado, United States - HRA Pharma Investigational Site
Denver, Colorado, United States - (and 31 more...)
|
|
| 20 |
NCT02634437 |
Completed |
Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Area under the plasma concentration versus time curve of ulipristal acetate from time 0 to time t (AUC 0-t)
- Maximum plasma drug concentration (Cmax) of ulipristal acetate
- Time of maximum plasma drug concentration (Tmax) of ulipristal acetate
- (and 14 more...)
|
19 |
Female |
18 Years to 80 Years (Adult, Older Adult) |
NCT02634437 |
UPA-PK-02 |
|
December 1, 2015 |
December 9, 2016 |
December 9, 2016 |
December 18, 2015 |
February 8, 2018 |
|
- Division of Clinical Pharmacology, University of Miami
Miami, Florida, United States - Clinical Pharmacology of Miami
Miami, Florida, United States - Orlando Clinical Research Center
Orlando, Florida, United States - (and 2 more...)
|
|
| 21 |
NCT03186586 |
Recruiting |
Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena |
- Heavy Menstrual Bleeding
- Abnormal Bleeding
|
- Drug: Ulipristal acetate
- Drug: Placebo
|
Interventional
|
Phase 4 |
- University of Campinas, Brazil
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Uterine bleeding control (stop bleeding)
- Endometrial control
|
32 |
Female |
18 Years to 45 Years (Adult) |
NCT03186586 |
CEMICAMP |
|
July 1, 2017 |
July 30, 2018 |
July 30, 2018 |
June 14, 2017 |
May 3, 2018 |
|
- University of Campinas
Campinas, SP, Brazil
|
|
| 22 |
NCT02361892 |
Unknown † |
The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve |
|
|
Interventional
|
Phase 4 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Ovarian age change after two courses of UPA
|
73 |
Female |
18 Years to 40 Years (Adult) |
NCT02361892 |
UPA and ovarian reserve |
UPA_ovAge |
February 2015 |
June 2017 |
September 2017 |
February 12, 2015 |
November 18, 2016 |
|
- Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, Italy
|
|
| 23 |
NCT02408770 |
Unknown † |
Breast Cancer - Anti-Progestin Prevention Study 1 |
|
|
Interventional
|
Phase 2 |
- Manchester University NHS Foundation Trust
- University of Manchester
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- change in the proliferation of normal breast epithelium, assessed by Ki67
- percentage of luminal basal and mixed colonies by adherent and FACS analyses
- Change in MRI background parenchymal enhancement assessed by BiRADs scoring
- proportion of participants with specific side effects from ulipristal acetate
|
30 |
Female |
25 Years to 45 Years (Adult) |
NCT02408770 |
UHSM0315 |
BC-APPS1 |
September 2015 |
December 2016 |
May 2017 |
April 3, 2015 |
October 27, 2015 |
|
|
|
| 24 |
NCT02147197 |
Completed |
A Study of the Efficacy and Safety of a Single Ulipristal Treatment Course for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas |
- Uterine Bleeding in Women With Leiomyomas
|
- Drug: Ulipristal acetate 5 mg
- Drug: Ulipristal acetate 10 mg
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Absence of bleeding
- Time to absence of bleeding
|
144 |
Female |
18 Years to 50 Years (Adult) |
NCT02147197 |
UL1309 |
|
April 2014 |
March 2016 |
April 2016 |
May 26, 2014 |
March 20, 2017 |
|
- Watson Investigational Site 125
Tucson, Arizona, United States - Watson Investigational Site 112
Denver, Colorado, United States - Watson Investigational Site 115
Lakewood, Colorado, United States - (and 22 more...)
|
|
| 25 |
NCT01953679 |
Completed |
Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days |
- Focus: Estrogen-free Oral Contraception
|
|
Interventional
|
Phase 2 |
- Health Decisions
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Ovulation inhibition
- Bleeding profile
- Follicle growth and rupture
- (and 2 more...)
|
180 |
Female |
18 Years to 35 Years (Adult) |
NCT01953679 |
CCN013 |
CCN013 |
March 2014 |
August 2015 |
November 2015 |
October 1, 2013 |
February 22, 2016 |
|
- California Family Health Council
Los Angeles, California, United States - University of California, San Francisco
San Francisco, California, United States - University of Colorado - Denver Anschutz Medical Campus
Aurora, Colorado, United States - (and 7 more...)
|
|
| 26 |
NCT00290251 |
Completed
Has Results |
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914 |
|
- Drug: ulipristal acetate
- Drug: placebo
|
Interventional
|
Phase 2 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- HRA Pharma
- National Institutes of Health Clinical Center (CC)
|
NIH / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Shrinkage of Fibroids - Size of Fibroids
- Quality of Life
|
72 |
Female |
25 Years to 50 Years (Adult) |
NCT00290251 |
060090
1ZIAHD000637-17
06-CH-0090 |
|
February 2006 |
July 2009 |
August 2010 |
February 10, 2006 |
December 18, 2012 |
December 18, 2012 |
- NIH Clinical Center
Bethesda, Maryland, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 27 |
NCT01642472 |
Completed |
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata |
|
- Drug: Ulipristal Acetate - open label
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Myoma symptom control assessed with a Global Study Treatment Satisfaction Questionnaire
|
64 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01642472 |
PGL11-024 |
PEARLext2 |
July 2012 |
March 2015 |
April 2015 |
July 17, 2012 |
January 8, 2016 |
|
- Medical University Vienna
Vienna, Austria - Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,
Brussels, Belgium - CHR de la Citadelle
Liège, Belgium - (and 13 more...)
|
|
| 28 |
NCT01553123 |
Withdrawn |
Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma |
|
- Drug: Ulipristal Acetate
- Drug: Iron
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in hemoglobin levels (g/dL)
|
0 |
Female |
18 Years to 50 Years (Adult) |
NCT01553123 |
UL1104 |
|
April 2012 |
November 2013 |
December 2013 |
March 13, 2012 |
February 7, 2013 |
|
- Alabama Clinical Therapeutics
Birmingham, Alabama, United States - Coastal Clinical Research, Inc
Mobile, Alabama, United States - Women's Health Research
Phoenix, Arizona, United States - (and 44 more...)
|
|
| 29 |
NCT01569737 |
Completed |
Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella |
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
|
98 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01569737 |
2914-012 |
ellipse II |
January 2012 |
June 29, 2018 |
June 29, 2018 |
April 3, 2012 |
July 30, 2018 |
|
- Planned Parenthood Federation of America, Inc
New York, New York, United States
|
|
| 30 |
NCT03421639 |
Recruiting |
Aromatase Plus GnRH Analogue Versus Ulippristal Acetate in Uterine Fibroids |
- Uterine Fibroid
- Uterine Bleeding
|
- Drug: Ulipristal acetate
- Drug: Aromatase inhibitor plus GnRH analog
|
Interventional
|
Phase 4 |
- Centre for Endocrinology and Reproductive Medicine, Italy
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- uterine volume (measured by ultrasound) decrease
- uterine bleeding (numbere of episodes)
|
150 |
Female |
30 Years to 45 Years (Adult) |
NCT03421639 |
CR-01-18 |
|
December 1, 2017 |
January 31, 2019 |
February 1, 2020 |
February 5, 2018 |
February 7, 2018 |
|
|
|
| 31 |
NCT03027973 |
Not yet recruiting |
Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding |
|
- Drug: UPA
- Drug: TEA
- Drug: Placebo (for UPA)
- Drug: Placebo (for TEA)
|
Interventional
|
Phase 1 |
- University of Saskatchewan
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change from Baseline Menorrhagia Multi-attribute Scale (MMAS) at 3 Months
- Number of adverse events that occur
|
60 |
Female |
18 Years to 51 Years (Adult) |
NCT03027973 |
PBLL07230904
16-155 |
|
March 2018 |
December 2018 |
July 2019 |
January 23, 2017 |
November 17, 2017 |
|
- Saskatoon Obstetric and Gynecologic Consultants
Saskatoon, Saskatchewan, Canada
|
|
| 32 |
NCT02425878 |
Completed |
Ulipristal Acetate 10 mg and Asisted Reproduction |
- Intramural Fibroids
- Uterine Fibroids
|
- Drug: Ulipristal Acetate
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Instituto Valenciano de Infertilidad, IVI VALENCIA
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- increase in the rate of clinical pregnancy
|
2 |
Female |
18 Years to 50 Years (Adult) |
NCT02425878 |
1311-BCN-138-DG |
|
May 2015 |
May 2016 |
May 2016 |
April 24, 2015 |
August 30, 2016 |
|
- IVI Valencia
Valencia, Spain
|
|
| 33 |
NCT02147158 |
Completed |
A Study of the Safety and Efficacy of Intermittent Ulipristal Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas |
- Uterine Bleeding in Women With Leiomyomas
|
- Drug: Ulipristal acetate (UPA) 5 mg
- Drug: Ulipristal acetate (UPA) 10 mg
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Absence of bleeding
- Time to absence of bleeding
|
432 |
Female |
18 Years to 50 Years (Adult) |
NCT02147158 |
UL1208 |
|
January 29, 2014 |
November 24, 2016 |
January 3, 2017 |
May 26, 2014 |
November 7, 2017 |
|
- Watson Investigational Site 138
Mesa, Arizona, United States - Watson Investigational Site 106
Phoenix, Arizona, United States - Watson Investigational Site 147
Phoenix, Arizona, United States - (and 54 more...)
|
|
| 34 |
NCT03156127 |
Withdrawn |
A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet |
|
- Drug: BR-UPS 5 mg tablet, Inisia 5 mg tablet
|
Interventional
|
Phase 1 |
- Boryung Pharmaceutical Co., Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
- AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate
|
0 |
Female |
19 Years to 45 Years (Adult) |
NCT03156127 |
BR-UPS-CT-101 |
|
May 19, 2017 |
July 2017 |
October 2017 |
May 17, 2017 |
August 10, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
|
| 35 |
NCT00791297 |
Completed |
Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 |
|
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.
- Regular follow-up of follicle diameter will be made with USS to determine the timing of ovulation or, in the absence of ovulation, the fate of the dominant follicle.
- Clinical safety will be evaluated and the effects on the endometrium will be measured.
|
55 |
Female |
21 Years to 40 Years (Adult) |
NCT00791297 |
Population Council #422 |
|
October 2008 |
September 2014 |
September 2014 |
November 14, 2008 |
August 15, 2017 |
|
- Oregon Health & Science University
Portland, Oregon, United States - Instituto Chileno de Medicina Reproductiva
Santiago, Chile - Profamilia
Santo Domingo, Dominican Republic
|
|
| 36 |
NCT02577601 |
Completed |
Impact of Combined Hormonal Contraceptives on UPA |
|
- Drug: Ulipristal Acetate
- Drug: Levonorgestrel (LNG)/Ethinyl estradiol birth control pill
|
Interventional
|
Phase 4 |
- Oregon Health and Science University
- Society of Family Planning
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Evidence of follicle rupture by day 5 following use of UPA measured by observing a collapse in the size of the dominant follicle (by 50%) with transvaginal ultrasound
|
51 |
Female |
18 Years to 35 Years (Adult) |
NCT02577601 |
OHSU IRB 11784 |
|
September 8, 2015 |
June 17, 2017 |
June 17, 2017 |
October 16, 2015 |
August 27, 2018 |
|
- Oregon Health & Science University
Portland, Oregon, United States
|
|
| 37 |
NCT01493791 |
Withdrawn |
CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women |
|
|
Interventional
|
Early Phase 1 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
|
- Primary outcome parameters will include bleeding symptoms evaluated by Menorrhagia Impact Questionnaire (MIQ), composite bleeding score, endometrial hyperplasia, changes in hemoglobin (g/dL)
- Quality of life as measured by surveys.
|
0 |
All |
25 Years to 50 Years (Adult) |
NCT01493791 |
120015
12-CH-0015 |
|
November 8, 2011 |
July 24, 2013 |
July 24, 2013 |
December 16, 2011 |
December 11, 2018 |
|
|
|
| 38 |
NCT01539720 |
Completed |
Levonorgestrel Intrauterine System For Emergency Contraception |
- Pregnancy, Unplanned
- Pregnancy; Accident
|
- Drug: Ulipristal acetate
- Device: levonorgestrel IUS
|
Interventional
|
Not Applicable |
- Washington University School of Medicine
- William and Flora Hewlett Foundation
- University of Colorado, Denver
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Pregnancy
- LARC use at 6 and 12 months
- Continuation and satisfaction among participants in the LNG-IUS arm
|
273 |
Female |
14 Years to 45 Years (Child, Adult) |
NCT01539720 |
201201007 |
LIFE |
December 2012 |
November 30, 2018 |
November 30, 2018 |
February 27, 2012 |
December 3, 2018 |
|
- Atlanta Women's Center
Atlanta, Georgia, United States - Indiana University School of Medicine
Indianapolis, Indiana, United States - Washington University School of Medicine in St. Louis
Saint Louis, Missouri, United States
|
|
| 39 |
NCT02689804 |
Completed
Has Results |
EC PK in Women With Normal and Obese BMI |
|
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
- Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
- Elimination Half-life of Serum LNG
- (and 7 more...)
|
34 |
Female |
18 Years to 45 Years (Adult) |
NCT02689804 |
AAAP1857 |
|
July 10, 2015 |
December 29, 2015 |
February 3, 2017 |
February 24, 2016 |
July 7, 2017 |
July 7, 2017 |
- Columbia University Medical Center
New York, New York, United States
|
|
| 40 |
NCT01107106 |
Completed |
Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women |
|
- Drug: ellaOne® (ulipristal acetate)
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
- Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception
|
579 |
Female |
Child, Adult, Older Adult |
NCT01107106 |
2914-010
2009-017771-21 |
|
May 2010 |
January 2013 |
February 2013 |
April 20, 2010 |
May 15, 2013 |
|
- PPRM Central clinic
Denver, Colorado, United States - PPRM Southwest clinic
Lakewood, Colorado, United States - Elizabeth Blackwell Health Center
Philadelphia, Pennsylvania, United States - (and 3 more...)
|
|
| 41 |
NCT01107093 |
Completed |
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge |
|
- Drug: CDB-2914 (ulipristal acetate)
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
|
- Inhibition of follicular rupture
- Appearance or absence of a corpus luteum
- Growth pattern of leading follicle
- (and 5 more...)
|
35 |
Female |
18 Years to 35 Years (Adult) |
NCT01107093 |
2914-007 |
|
May 2008 |
December 2008 |
December 2008 |
April 20, 2010 |
August 25, 2010 |
|
- ICMER
Santiago, Chile - Clinica de PROFAMILIA
Santo Domingo, Dominican Republic
|
|
| 42 |
NCT01337206 |
Completed |
SX ELLA Esophageal Degradable BD Stent System |
- Benign Esophageal Lesions
|
- Device: Stenting with ELLA Biodegradable stent
- Procedure: Standard Dilations
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
- Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion
- Time to recurrent significant dysphagia
- (and 7 more...)
|
66 |
All |
18 Years and older (Adult, Older Adult) |
NCT01337206 |
09-024 |
DESTINY |
January 2012 |
July 2014 |
January 2015 |
April 18, 2011 |
February 6, 2015 |
|
- Clinique Universitaire Saint Luc
Brussels, Belgium - University Hospitals Leuven
Leuven, Belgium - IRCCS Istituto Clinico Humanitas
Milan, Italy - (and 5 more...)
|
|
| 43 |
NCT02440750 |
Unknown † |
Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women |
|
- Procedure: operative hysteroscopy
- Drug: Dienogest
- Drug: Ulipristal acetate
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Endometrial thickness
- Ovarian follicle dimensions
- Endometrial appearance
- Operative time
|
50 |
Female |
18 Years to 50 Years (Adult) |
NCT02440750 |
HYSTERO |
|
June 2016 |
April 2017 |
June 2017 |
May 12, 2015 |
March 9, 2016 |
|
|
|
| 44 |
NCT03230539 |
Recruiting |
A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA) |
|
- Drug: Ulipristal Acetate IUS delivering Cu and 5μg
- Drug: Ulipristal Acetate IUS delivering Cu and 20μg
- Drug: Ulipristal Acetate IUS delivering Cu and 40μg
|
Interventional
|
Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- The primary endpoint is the ability of the three doses of UPA as delivered by IUS to suppress bleeding.
|
30 |
Female |
21 Years to 38 Years (Adult) |
NCT03230539 |
719 |
|
May 1, 2017 |
January 2018 |
May 2018 |
July 26, 2017 |
August 15, 2017 |
|
- Profamilia
Santo Domingo, Dominican Republic
|
|
| 45 |
NCT02748460 |
Recruiting |
Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Occurrence of gynaecological AEs, SAEs, non-serious ADRs, AEs leading to ESMYA treatment discontinuation
|
1500 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02748460 |
PGL14-001 (PREMIUM) |
Premium |
December 2015 |
December 2022 |
December 2022 |
April 22, 2016 |
December 8, 2016 |
|
- Centre Hospitalier Regional De La Citadelle
Liege, Belgium - Clinique Universitaire de Mont Godinne
Yvoir, Belgium - Gyn-Porodnicka Klinika Fn Brno
Brno, Czech Republic - (and 66 more...)
|
|
| 46 |
NCT03533907 |
Completed |
Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate. |
- Myoma;Uterus
- Infertility, Female
|
|
Observational
|
|
- Istituto Clinico Humanitas
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- implantation rate
- myomas reduction
|
20 |
Female |
18 Years to 45 Years (Adult) |
NCT03533907 |
8/2018 |
|
November 1, 2013 |
April 10, 2018 |
May 1, 2018 |
May 23, 2018 |
June 8, 2018 |
|
- Paolo Emanuele Levi Setti
Rozzano, MI, Italy
|
|
| 47 |
NCT02600286 |
Terminated |
Ulipristal Acetate In Disease Charcot-Marie-Tooth Type of 1A |
|
- Drug: EllaOne
- Drug: EllaOne placebo
|
Interventional
|
Phase 2 |
- University Hospital, Strasbourg, France
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Analysis of the effectiveness of Ellaone. This will be assessed by the production of RNA PMP22 using skin biopsy.
|
23 |
Male |
18 Years to 70 Years (Adult, Older Adult) |
NCT02600286 |
6100 |
UPACOMT |
October 23, 2015 |
November 2017 |
November 2, 2017 |
November 9, 2015 |
May 25, 2018 |
|
- Département de Neurologie Centre de Référence des Maladies Neuromusculaires Grand Est (CERNEST) Hôpital de Hautepierre
Strasbourg, France
|
|
| 48 |
NCT00456924 |
Completed |
Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914 |
- Contraception
- Gynecologic Diseases
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- ovarian hormones
- follicular development
- endometrial histology
- (and 5 more...)
|
48 |
Female |
18 Years to 35 Years (Adult) |
NCT00456924 |
2914-002 |
|
January 2004 |
|
December 2004 |
April 5, 2007 |
June 17, 2010 |
|
- Liege University Hospital
Liege, Belgium - Sainte Rosalie Clinique
Liege, Belgium - Antoine Beclere Hospital
Clamart, France - Saint Antoine Hospital
Paris, France
|
|
| 49 |
NCT00411684 |
Completed |
Safety and Efficacy of CDB-2914 for Emergency Contraception |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pregnancy rate
- Prevented fraction (number of prevented pregnancies divided by the number of expected pregnancies)
- Impact on menstrual bleeding patterns
- Frequencies of subjects with treatment emergent adverse events
|
1320 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00411684 |
2914-005 |
|
November 2006 |
|
|
December 14, 2006 |
June 17, 2010 |
|
- Planned Parenthood of Mar Monte
San Jose, California, United States - Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States - Planned Parenthood of Greater Miami, Palm Beach and Treasure Cost
Miami, Florida, United States - (and 14 more...)
|
|
| 50 |
NCT00009659 |
Completed |
Use of the Synthetic Hormone CDB-2914 in Treating Symptoms of Menopause |
|
|
Interventional
|
Phase 2 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
58 |
Female |
Child, Adult, Older Adult |
NCT00009659 |
010081
01-CH-0081 |
|
January 2001 |
|
December 2001 |
February 5, 2001 |
March 4, 2008 |
|
- National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States
|
|
| 51 |
NCT00044876 |
Completed |
Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist |
|
|
Interventional
|
Phase 2 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
56 |
Female |
33 Years to 50 Years (Adult) |
NCT00044876 |
020287
02-CH-0287 |
|
September 2, 2002 |
June 16, 2007 |
October 1, 2015 |
September 6, 2002 |
December 5, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 52 |
NCT00271583 |
Completed |
Efficacy Trial of CDB 2914 for Emergency Contraception |
|
- Drug: CDB-2914
- Drug: levonorgestrel
|
Interventional
|
Phase 2
Phase 3 |
- University of Pittsburgh
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Pregnancy (efficacy)
- Tolerability (side effects)
- Menstrual cycle effects
|
1672 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00271583 |
CCN002
N01-HD-9-3298 |
|
September 1999 |
|
September 2001 |
January 2, 2006 |
December 17, 2007 |
|
- California Family Health Council
Los Angeles, California, United States - University of Colorado
Denver, Colorado, United States - New York University
New York, New York, United States - (and 3 more...)
|
|
| 53 |
NCT01635452 |
Unknown † |
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.
|
1500 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01635452 |
PGL10-014 |
PREMYA |
May 2012 |
April 2014 |
March 2016 |
July 9, 2012 |
January 27, 2015 |
|
- LKH Klagenfurt
Klagenfurt, Austria - Private practice
St Pölten, Austria - CHU Pellegrin Gynécologie
Bordeaux, France - (and 72 more...)
|
|
| 54 |
NCT00041899 |
Completed |
Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914 |
|
- Drug: CDB-2914
- Drug: COB-2914
|
Interventional
|
Phase 1 |
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
15 |
Female |
Child, Adult, Older Adult |
NCT00041899 |
020219
02-CH-0219 |
|
May 2002 |
|
March 2005 |
July 19, 2002 |
March 4, 2008 |
|
- National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States
|
|
| 55 |
NCT00755755 |
Completed
Has Results |
PGL4001 Versus Placebo in Uterine Myomas |
|
- Drug: PGL4001 (ulipristal) and iron
- Drug: PGL4001 matching placebo and iron
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)
- Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)
|
241 |
Female |
18 Years to 50 Years (Adult) |
NCT00755755 |
PGL07-021 |
PEARLI |
October 2008 |
March 2010 |
August 2010 |
September 19, 2008 |
December 13, 2012 |
November 16, 2012 |
- Gynekologicko-porodnicka klinika FN Brno
Brno, Czech Republic - Mediva
Praha, Czech Republic - Gynekologicko-porodnicka klinika 1.LF UK a VFN
Praha, Czech Republic - (and 35 more...)
|
|
| 56 |
NCT00929942 |
Completed |
Biodegradable Stents in Lung Transplantation |
|
- Device: SX-ELLA Stent Degradable DV Bronchial (DV Stent)
|
Interventional
|
Phase 1 |
- Hannover Medical School
- ELLA-CS, Czech Republic
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.
- To demonstrate mucosal healing in the first 6 months after stent insertion.
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT00929942 |
5237 |
|
June 2009 |
April 2011 |
April 2011 |
June 30, 2009 |
July 22, 2011 |
|
- Hannover Medical School
Hannover, Germany
|
|
| 57 |
NCT03537768 |
Recruiting |
Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg |
|
- Drug: Ulipristal Acetate
- Drug: Levonorgestrel
|
Interventional
|
Phase 4 |
- Health Decisions
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Incidence of pregnancies of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥ 80 kg for emergency contraception (within 72 hours of unprotected intercourse).
- Incidence of treatment emergent adverse events of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg in women with weight ≥80 kg seeking emergency contraception.
|
1200 |
Female |
18 Years to 40 Years (Adult) |
NCT03537768 |
CCN013C |
|
July 12, 2018 |
August 1, 2019 |
August 1, 2019 |
May 25, 2018 |
August 1, 2018 |
|
- Essential Access Health
Los Angeles, California, United States - University of California, Davis
Sacramento, California, United States - University of California, San Francisco
San Francisco, California, United States - (and 15 more...)
|
|
| 58 |
NCT02859337 |
Recruiting |
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA |
|
- Drug: UPA-ECx1
- Drug: UPA-ECx2
|
Interventional
|
Phase 4 |
- Oregon Health and Science University
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Delay in follicular rupture
- Maximum serum concentration
|
112 |
Female |
18 Years to 35 Years (Adult) |
NCT02859337 |
OHSU IRB 016291 |
UPA-Obesity |
May 30, 2017 |
October 2021 |
October 2021 |
August 9, 2016 |
September 25, 2018 |
|
- OHSU
Portland, Oregon, United States
|
|
| 59 |
NCT01569113 |
Completed |
Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo. |
|
- Drug: Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)
- Drug: placebo + ethinylestradiol/levonorgestrel
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).
- Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.
|
76 |
Female |
18 Years to 35 Years (Adult) |
NCT01569113 |
2914-015 |
|
March 2012 |
August 2012 |
August 2012 |
April 2, 2012 |
June 13, 2013 |
|
- Dinox
Groningen, Netherlands - Karolinska University Hospital Solna
Stockholm, Sweden - Chalmers Sexual Health Clinic
Edinburgh, Scotland, United Kingdom
|
|
| 60 |
NCT00551616 |
Completed |
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception |
|
- Drug: CDB-2914
- Drug: Levonorgestrel
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Pregnancy rate
- Prevented fraction (number of prevented pregnancies divided by number of expected pregnancies)
- Menstrual bleeding patterns
- Frequencies of subjects with treatment emergent adverse events
|
2321 |
Female |
16 Years and older (Child, Adult, Older Adult) |
NCT00551616 |
2914-004 |
|
April 2007 |
April 2009 |
April 2009 |
October 31, 2007 |
June 17, 2010 |
|
- Planned Parenthood Hollywood
Los Angeles, California, United States - Planned Parenthood Santa Monica
Santa Monica, California, United States - Planned Parenthood of the Rocky Mountains
Boulder, Colorado, United States - (and 30 more...)
|
|
| 61 |
NCT03240523 |
Active, not recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Compare to Ulipristal |
|
- Drug: Vilaprisan (BAY1002670)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Amenorrhea (yes/no)
- Total volume of menstrual blood loss
- Number of bleeding days
- (and 4 more...)
|
1000 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03240523 |
15789
2016-002855-48 |
ASTEROID 5 |
July 31, 2017 |
September 16, 2021 |
September 16, 2021 |
August 7, 2017 |
December 11, 2018 |
|
- Paratus Clinical Pty Ltd
Blacktown, New South Wales, Australia - Paratus Clinical Wyong Complex
Kanwal, New South Wales, Australia - Women's Health and Research Institute of Australia-WHRIA
Sydney, New South Wales, Australia - (and 204 more...)
|
|
| 62 |
NCT02465814 |
Completed |
Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids |
|
- Drug: Vilaprisan (BAY1002670)
- Drug: Vilaprisan (BAY1002670
- Drug: Ulipristal
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Amenorrhea (yes/no)
- Number of bleeding days
- Time to onset of controlled bleeding
- (and 3 more...)
|
120 |
Female |
18 Years to 50 Years (Adult) |
NCT02465814 |
17541
2014-004221-41 |
ASTEROID 2 |
June 2015 |
October 2016 |
October 2016 |
June 9, 2015 |
November 22, 2016 |
|
- Villach, Kärnten, Austria
- Graz, Steiermark, Austria
- Innsbruck, Tirol, Austria
- (and 61 more...)
|
|
| 63 |
NCT02620319 |
Unknown † |
Biodegradable Stents in the Management of Stenoses of the Large Airways |
|
- Device: SX-ELLA Stent DV Tracheal (DV Stent)
|
Interventional
|
Not Applicable |
- Ludek Stehlik
- Ministry of Health, Czech Republic
- University Hospital Olomouc
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- airway patency during the presence of the stent in the airways
- number of complications: infection, bleeding, migration, obstructive granulation tissue formation, sudden restenosis (of any origin, unexpected in relation to the degree of the stent degradation)
- evaluation of forced expiratory volume in 1 second (FEV1)
- (and 2 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02620319 |
NT 14146-3/2013
NT14146 |
|
May 2013 |
December 2016 |
December 2016 |
December 3, 2015 |
June 17, 2016 |
|
- Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc
Olomouc, Czech Republic - Department of Respiratory Medicine, Thomayer Hospital
Prague, Czech Republic - Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital
Prague, Czech Republic
|
|
| 64 |
NCT02078414 |
Completed |
Continued Use of Effective Contraception After Use of Emergency Contraception |
- Emergency Contraception
- Contraception
- Reproductive Health
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Use of an effective contraceptive method
|
7 |
Female |
18 Years to 45 Years (Adult) |
NCT02078414 |
RFSU1 |
|
March 2014 |
February 2015 |
|
March 5, 2014 |
November 26, 2015 |
|
- RFSU clinic
Stockholm, Sweden
|
|
| 65 |
NCT01252069 |
Completed |
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study) |
|
- Drug: PGL4001, placebo, drug free period
- Drug: PGL4001, progestin, drug free period
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- percentage of subjects in amennorrhoea at the end of each PGL4001 treatment course received
|
132 |
Female |
18 Years to 48 Years (Adult) |
NCT01252069 |
PGL09-027 |
|
January 2011 |
August 2013 |
January 2014 |
December 2, 2010 |
January 13, 2016 |
|
- Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria - Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
Bruxelles, Belgium - CHR de la Citadelle Gynécologie-Obstétrique
Liège, Belgium - (and 15 more...)
|
|
| 66 |
NCT01156857 |
Completed |
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata |
|
- Drug: PGL4001, placebo
- Drug: PGL4001, progestin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Efficacy endpoints
- Number and proportion of subjects experiencing open label treatment-emergent adverse events
|
209 |
Female |
18 Years to 48 Years (Adult) |
NCT01156857 |
PGL09-026 |
PEARLIII |
July 2010 |
November 2011 |
February 2012 |
July 5, 2010 |
January 15, 2016 |
|
- Medical University Graz, department of obstetrics and gynecology
Graz, Austria - Medical University Vienna, department of obstetrics and gynecology
Vienna, Austria - Cliniques Universitaires Saint-Luc
Bruxelles, Belgium - (and 20 more...)
|
|
| 67 |
NCT00280709 |
Completed |
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction |
- Bile Duct Obstruction
- Pancreatic Cancer
- Gallbladder Cancer
- Bile Duct Cancer
|
- Device: "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
|
Interventional
|
Phase 4 |
- University Hospital, Linkoeping
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical follow-up every month, starting one month after stent insertion. Clinical and/or laboratory signs of stent dysfunction?
|
400 |
All |
20 Years and older (Adult, Older Adult) |
NCT00280709 |
ELLA |
|
January 2006 |
October 2008 |
August 2010 |
January 23, 2006 |
August 10, 2011 |
|
- Department of Surgery, University Hospital
Linkoping, Sweden
|
|
| 68 |
NCT00089414 |
Terminated
Has Results |
Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives |
- Premenstrual Syndrome
- PMS
- Premenstrual Dysphoric Disorder
- (and 2 more...)
|
- Drug: Ethinyl Estradiol/Drospirenone
- Drug: Placebo
- Drug: CDB 2914
|
Interventional
|
Phase 2 |
- National Institute of Mental Health (NIMH)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.
- Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.
- Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms
|
5 |
Female |
18 Years to 45 Years (Adult) |
NCT00089414 |
040221
04-M-0221 |
|
July 2004 |
June 2010 |
June 2010 |
August 5, 2004 |
August 25, 2017 |
January 2, 2017 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 69 |
NCT00496288 |
Recruiting |
Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer |
|
- Radiation: Prophylactic radiation to the contralateral breast
|
Interventional
|
Phase 2 |
- Assaf-Harofeh Medical Center
- Rambam Health Care Campus
- Tel-Aviv Sourasky Medical Center
- (and 4 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Rate of contralateral breast cancer in carrier patients that received prophylactic radiation to the contralateral breast compared with carrier patients that did not receive that treatment.
- Short and long term adverse effects of prophylactic contralateral breast irradiation.
- factors that influence patient's choice of treatment
|
240 |
Female |
30 Years to 90 Years (Adult, Older Adult) |
NCT00496288 |
102/07 (HT4351) |
|
March 2008 |
March 2023 |
|
July 4, 2007 |
April 5, 2011 |
|
- Assaf-Harofeh Medical Center
Zerrifin, Israel
|
|
| 70 |
NCT00740831 |
Completed
Has Results |
PGL4001 Versus GnRH-agonist in Uterine Myomas |
|
- Drug: PGL4001
- Drug: leuprorelin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
- Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
- Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
- Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
|
301 |
Female |
18 Years to 50 Years (Adult) |
NCT00740831 |
PGL07-022 |
PEARLII |
August 2008 |
January 2010 |
June 2010 |
August 25, 2008 |
December 17, 2012 |
November 16, 2012 |
- Medical University Graz
Graz, Austria - Medical University of Innsbruck
Innsbruck, Austria - Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology
Neunkirchen, Austria - (and 43 more...)
|
|
| 71 |
NCT02863445 |
Recruiting |
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG |
|
- Drug: Levonorgestrel-based emergency contraception 1.5 mg
- Drug: Levonorgestrel-based emergency contraception 3.0mg
|
Interventional
|
Phase 4 |
- Oregon Health and Science University
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of obese women with no follicle rupture (yes/no) between the two treatment groups (1.5mg levonorgestrel and 3mg levonorgestrel)
|
80 |
Female |
18 Years to 35 Years (Adult) |
NCT02863445 |
OHSU IRB 16291 |
EC-Obesity |
May 30, 2017 |
October 2021 |
October 2021 |
August 11, 2016 |
September 25, 2018 |
|
- OHSU
Portland, Oregon, United States
|
|
| 72 |
NCT02353286 |
Completed |
Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent |
|
- Device: Endoscopic insertion of biodegradable biliary stent
|
Interventional
|
Not Applicable |
- Tampere University Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical treatment success of stricture or leakage, treatment failure rate measured by change in treatment protocol or unplanned interventions, radiologic stricture diameter in MRI, radiologic stent degradation in MRI
- ERCP complications, late adverse events during stent therapy
- Technical success of stent insertion
|
14 |
All |
18 Years and older (Adult, Older Adult) |
NCT02353286 |
Biodegradable Biliary stent |
|
May 2014 |
December 31, 2017 |
December 31, 2017 |
February 2, 2015 |
May 14, 2018 |
|
- Tampere University Hospital, Dept. of Gastroenterology and Alimentary Tract Surgery
Tampere, Finland
|
|
| 73 |
NCT01834027 |
Completed
Has Results |
The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy |
|
- Behavioral: Jazz music
- Behavioral: No music
|
Interventional
|
Not Applicable |
- Milton S. Hershey Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Change in Heart Rate From Baseline on Arrival in PACU
- Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
- Mean Difference in Patient's Perception of Pain From Baseline
- Mean Blood Pressure
|
56 |
Female |
18 Years to 75 Years (Adult, Older Adult) |
NCT01834027 |
IRB 40925 |
|
March 2013 |
January 2014 |
January 2014 |
April 17, 2013 |
April 15, 2016 |
August 22, 2014 |
- Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
|
|
| 74 |
NCT03774368 |
Not yet recruiting
New |
Targeted Video Messaging About Emergency Contraception |
|
- Other: Emergency contraception website
- Other: Emergency contraception video
|
Interventional
|
Not Applicable |
- Planned Parenthood League of Massachusetts
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Emergency contraception knowledge (binary)
- Copper IUD as emergency contraception knowledge
- Levonorgestrel pill as emergency contraception knowledge
- (and 4 more...)
|
150 |
Female |
18 Years to 29 Years (Adult) |
NCT03774368 |
2018P001764 |
|
January 1, 2019 |
December 31, 2019 |
December 31, 2019 |
December 13, 2018 |
December 13, 2018 |
|
|
|
| 75 |
NCT03412526 |
Not yet recruiting |
Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian |
- Metastatic Ovarian Cancer
|
- Drug: Fludarabine
- Radiation: Radiation
- Biological: TIL administration
- Drug: IL-2
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Tumor responses
- Assess adverse events using NCI CTCAE V.4.03 during treatment and follow up
- Overall survival (OS)
- (and 3 more...)
|
15 |
Female |
18 Years to 80 Years (Adult, Older Adult) |
NCT03412526 |
SHEBA-16-3568-JS-TIL Ovarian |
|
January 31, 2018 |
February 1, 2021 |
February 1, 2022 |
January 26, 2018 |
January 30, 2018 |
|
- Sheba medical Center
Ramat Gan, Israel
|
|
| 76 |
NCT02580578 |
Active, not recruiting |
A Multicenter Prospective Non-Interventional Study Assessing the Management of Canadian Women With Uterine Fibroids |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Uterine Fibroid Symptom Quality of Life 37-Item Questionnaire (UFS QoL)
- Ruta Menorrhagia (Bleeding) 15-Item Questionnaire
- Number of Participants with Adverse Drug Reactions
|
1501 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02580578 |
CMO-CAN-WH-0412 |
|
July 31, 2015 |
February 13, 2020 |
February 13, 2020 |
October 20, 2015 |
August 8, 2018 |
|
- Peter Lougheed Centre/University of Calgary
Calgary, Alberta, Canada - Urestky Edmonton Clinic
Edmonton, Alberta, Canada - Sanders Vancouver Clinic
Vancouver, British Columbia, Canada - (and 17 more...)
|
|
| 77 |
NCT01629563 |
Completed |
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata |
|
- Drug: PGL4001 5 mg
- Drug: PGL4001 10 mg
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of subjects who are in amenorrhea at the end of all four treatment courses
- Percentage of subjects with controlled bleeding
- Change from baseline in myoma volume
- (and 3 more...)
|
451 |
Female |
18 Years to 50 Years (Adult) |
NCT01629563 |
PGL11-006 |
PEARLIV |
June 2012 |
January 2015 |
January 2015 |
June 27, 2012 |
December 8, 2015 |
|
- Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique
Brussels, Belgium - UZ Leuven Campus Gasthuisberg
Leuven, Belgium - CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique
Liège, Belgium - (and 46 more...)
|
|
| 78 |
NCT03604185 |
Not yet recruiting |
Effects of Short-term Choir Participation on Auditory Perception in Hearing-aided Older Adults. |
- Hearing Loss
- Auditory Perception
- Music Therapy
- Aging
|
- Behavioral: Choir Singing
- Behavioral: Music Appreciation
|
Interventional
|
Not Applicable |
- Ryerson University
- Sonova AG
- Mitacs
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Speech-in-noise perception: Signal-to-Noise Ratio (SNR)
- Pitch discrimination: Frequency Difference Limens (FDL)
- Frequency Following Response (FFR)
|
60 |
All |
50 Years and older (Adult, Older Adult) |
NCT03604185 |
2018-089 |
|
September 1, 2018 |
November 1, 2019 |
August 1, 2020 |
July 27, 2018 |
August 21, 2018 |
|
- Ryerson University
Toronto, Ontario, Canada
|
|
| 79 |
NCT01242280 |
Completed |
Self-expandable Esophageal Stent Versus Balloon Tamponade in Refractory Esophageal Variceal Bleeding. |
- Esophageal Varices
- Bleeding
- Cirrhosis
|
- Device: Stent
- Device: Tamponade
|
Interventional
|
Phase 3 |
- Hospital Clinic of Barcelona
- Germans Trias i Pujol Hospital
- Hospital Universitario Ramon y Cajal
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Combined: bleeding + absence of severe adverse events + survival
- Bleeding
- Survival
- (and 5 more...)
|
28 |
All |
18 Years and older (Adult, Older Adult) |
NCT01242280 |
PE08001 |
|
January 2010 |
June 2014 |
June 2014 |
November 17, 2010 |
February 5, 2015 |
|
- Hospital Clinic
Barcelona, Spain
|
|
| 80 |
NCT02847338 |
Recruiting |
Comparison of Optimal Hypertension Regimens |
|
- Drug: Amlodipine
- Drug: Lisinopril
- Drug: Amiloride
- Drug: Chlortalidone
|
Interventional
|
Phase 4 |
- Cambridge University Hospitals NHS Foundation Trust
- Medical Research Council
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Seated Automated Office Systolic Blood Pressure
- Seated Automatic office systolic blood pressure
- Core Cardiovascular Measurements
- (and 3 more...)
|
1320 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02847338 |
AO94005 |
AIMHY-INFORM |
November 2016 |
November 2020 |
November 2021 |
July 28, 2016 |
July 9, 2018 |
|
- Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom - Queen Elizabeth Hospital
Birmingham, United Kingdom - Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, United Kingdom - (and 9 more...)
|
|
| 81 |
NCT02321163 |
Unknown † |
Electrical Stimulation for Attenuating Muscle Atrophy |
|
- Device: NMES new paradigm
- Device: NMES conventional
- Device: NMES no stimulation
|
Interventional
|
Not Applicable |
- The Hong Kong Polytechnic University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Muscle cross sectional area (quadriceps and calf muscles)
- Isometric knee extensor and plantarflexor muscle torque
- Muscle activation (Twitch interpolation technique will be used to assess the voluntary muscle activation)
- (and 2 more...)
|
105 |
All |
35 Years to 80 Years (Adult, Older Adult) |
NCT02321163 |
HMRF12131991 |
|
February 2016 |
December 2016 |
May 2017 |
December 22, 2014 |
February 25, 2016 |
|
- Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Hung Hom, Hong Kong
|
|
| 82 |
NCT01152983 |
Unknown † |
Safety and Performance Evaluation of the Rapid Ring Device |
|
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Collection of at least 2 drops (approximately 50microliter) of blood within one minute.
- Reduction in pain
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT01152983 |
CTIL - CL-001 |
|
August 2010 |
November 2010 |
November 2010 |
June 29, 2010 |
June 29, 2010 |
|
- Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
|
|
| 83 |
NCT03268733 |
Recruiting |
The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome |
- Polycystic Ovary Syndrome
|
|
Interventional
|
Phase 1
Phase 2 |
- University of Khartoum
- Awad, Mohamed Ibrahim, M.D.
- Duria abdulwahab Elrrayes
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pregnancy rates
- Ovulatory pattern improvements
- Clinical signs of hyperandrogenemia
- (and 4 more...)
|
90 |
Female |
20 Years to 40 Years (Adult) |
NCT03268733 |
Folic acid in PCOS |
FolicacidPCOS |
September 1, 2017 |
September 1, 2018 |
September 1, 2019 |
August 31, 2017 |
August 31, 2017 |
|
- Saad Abul ella fertility Centre
Khartoum, Sudan
|
|
| 84 |
NCT01799668 |
Unknown † |
Therapists' Preferences for Client Characteristics and Their Influence on the Therapeutic Alliance |
- Diagnosis, Psychiatric
- Outpatient Followup of Psychiatric Problem
|
|
Observational
|
|
- Hillel Yaffe Medical Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Positive correlation between preferences- characteristics match and therapeutic alliance.
|
200 |
All |
18 Years and older (Adult, Older Adult) |
NCT01799668 |
0001-13 HYMC |
|
February 2013 |
October 2013 |
October 2013 |
February 27, 2013 |
February 27, 2013 |
|
- Hillel Yaffe Medical Center
Hadera, Israel
|
|
| 85 |
NCT03429920 |
Recruiting |
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors |
- Cardiovascular Risk Factor
- Heart Diseases
- Inflammation
|
- Dietary Supplement: Q CAN PLUS
- Dietary Supplement: Placebo
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- To test the effects of Q CAN PLUS powder, on serum lipids
- Inflammatory parameter
- Fasting Glucose
|
31 |
All |
35 Years to 75 Years (Adult, Older Adult) |
NCT03429920 |
2160353 |
FS |
September 23, 2018 |
March 24, 2019 |
March 31, 2020 |
February 12, 2018 |
October 29, 2018 |
|
- Loma Linda University
Loma Linda, California, United States
|
|
| 86 |
NCT00228202 |
Unknown † |
Genotyping of Cytomegalovirus From Patients in Israel |
- Cytomegalovirus Infections
|
|
Observational
|
|
|
Other |
- Observational Model: Natural History
- Time Perspective: Cross-Sectional
- Time Perspective: Retrospective
|
|
100 |
All |
Child, Adult, Older Adult |
NCT00228202 |
SHEBA-05-3867-NK-CTIL
Sara Orzi MSc thesis |
|
September 2005 |
|
|
September 28, 2005 |
August 18, 2006 |
|
- Central Virology Laboratory, Chaim Sheba Medical Center Tel-Hashomer
Ramat Gan, Israel
|
|
| 87 |
NCT01988077 |
Terminated |
Clinical Evaluation of Yervoy in Combination With Adoptive T Cell Transfer for Metastatic Melanoma Patients |
- A Combination of Adoptive T Cell Therapy and Ipilimumab Could Increase the Proportion of CR Patients, and Durability of Response
|
- Biological: Adoptive cell transfer
- Drug: Ipilimumab 5 MG/ML Injection [Yervoy]
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the response rate of the combination of ipilimumab with young TIL protocol and the CR rate of this combination according to modified RECIST 1.1.
- • Evaluate the toxicity of this treatment regimen.
|
2 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01988077 |
Ipilimumab TIL |
|
October 2013 |
May 2016 |
October 2018 |
November 20, 2013 |
May 23, 2017 |
|
- Sheba. Medical Center
Ramat Gan, Israel
|
|
| 88 |
NCT03353402 |
Recruiting |
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy |
- Melanoma Stage Iv
- Unresectable Stage III Melanoma
|
- Procedure: Fecal Microbiota Transplant (FMT)
|
Interventional
|
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of FMT-related Adverse Events
- Proper implant engraftment
- Changes in composition of immune cell population
- Changes in activity of immune cells
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT03353402 |
SHEBA-17-3956-GM |
|
November 30, 2017 |
December 30, 2019 |
December 30, 2021 |
November 27, 2017 |
February 26, 2018 |
|
- Sheba Medical Center
Tel HaShomer, Israel
|
|
| 89 |
NCT03189927 |
Not yet recruiting |
BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study |
- Benign Esophageal Stricture
|
- Device: BD-Covered esophageal stent
|
Interventional
|
Not Applicable |
- Radboud University
- ELLA-CS
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of treatment associated adverse events during follow-up (safety)
- BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
- Esophageal pain, measured with VAS during follow-up after stent placement
- Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
|
15 |
All |
18 Years and older (Adult, Older Adult) |
NCT03189927 |
NL.59222.091.16 |
BIDARCA |
July 1, 2017 |
July 1, 2018 |
January 1, 2019 |
June 16, 2017 |
June 16, 2017 |
|
|
|
| 90 |
NCT00287131 |
Unknown † |
Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients |
|
- Procedure: Procedure - Adoptive cell transfer
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate and toxicity
|
70 |
All |
18 Years and older (Adult, Older Adult) |
NCT00287131 |
SHEBA-04-3518-JS-CTIL |
|
January 2006 |
December 2012 |
November 2013 |
February 6, 2006 |
March 29, 2012 |
|
- Sheba Medical Center
Tel hashomer, Israel
|
|
| 91 |
NCT03675152 |
Recruiting |
Treatment of Spondylolysisin Pediatric Patients. |
- Low Back Pain
- Stress Fracture
|
- Other: Soft spinal brace
- Other: thoracolumbar orthosis
- Other: Excersice restriction
|
Interventional
|
Not Applicable |
- Turku University Hospital
- Satakunta Central Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Healing of spondylolysis in computed tomography
- developement of spondylolisthesis
- Pain measurement 1: Oswestry disability index
- (and 11 more...)
|
60 |
All |
8 Years to 20 Years (Child, Adult) |
NCT03675152 |
T45/2016 |
|
June 12, 2016 |
December 21, 2021 |
December 21, 2022 |
September 18, 2018 |
October 5, 2018 |
|
- Satakunta central hospital
Pori, Finland - Turku university hospital
Turku, Finland
|
|
| 92 |
NCT02381457 |
Recruiting |
SNP-based Microdeletion and Aneuploidy RegisTry (SMART) |
- 22q11 Deletion Syndrome
- DiGeorge Syndrome
- Trisomy 21
- (and 8 more...)
|
|
Observational
|
|
- Natera, Inc.
- George Washington University
- University of California, San Francisco
- (and 2 more...)
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- 22q11.2 Snp-based non-invasive prenatal screening test performance, including positive predictive value (PPV), specificity, and sensitivity
- Combined microdeletion syndrome screening test performance
- No call rate
- (and 3 more...)
|
10000 |
Female |
18 Years to 48 Years (Adult) |
NCT02381457 |
14-024-NPT |
SMART |
April 2015 |
August 2019 |
December 2019 |
March 6, 2015 |
September 25, 2017 |
|
- University of California, San Francisco
San Francisco, California, United States - St. Peter's University
New Brunswick, New Jersey, United States - Complete Women's Healthcare
Garden City, New York, United States - (and 15 more...)
|
|
| 93 |
NCT02979119 |
Recruiting |
The European Paediatric Network for Haemophilia Management ( PedNet Registry) |
- Factor VIII Deficiency
- Factor IX Deficiency
|
- Drug: Coagulation proteins
|
Observational
|
|
- PedNet Haemophilia Research Foundation
- Lund University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of patients with antibody development to exogenous clotting factors
- Long term outcome of haemophilia on joint status using the Hemophilia Joint Health Score (HJHS) and MRI techniques.
- Long term outcome different Immune Tolerance Induction (ITI) therapies in patients with inhibitor.
|
2200 |
All |
Child, Adult, Older Adult |
NCT02979119 |
Version 5.1 June 2014 |
PedNet |
June 2014 |
December 2019 |
December 2019 |
December 1, 2016 |
November 6, 2017 |
|
- Universitäts-Klinik für Kinder- und Jugendheilkunde
Graz, Austria - Medical University of Vienna - Department of Paediatrics
Vienna, Austria - Service of Pediatric Haematology University Hospital Leuven
Leuven, Belgium - (and 32 more...)
|
|
| 94 |
NCT02203695 |
Recruiting |
Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy |
- Adenocarcinoma of the Prostate
|
- Drug: Enzalutamide
- Radiation: SRT
|
Interventional
|
Phase 2 |
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Astellas Pharma Inc
- Medivation, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Freedom of PSA (Prostate Specific Antigen) progression
- Local recurrence
- Metastatic free survival rate
- (and 3 more...)
|
122 |
Male |
18 Years to 100 Years (Adult, Older Adult) |
NCT02203695 |
J1454
IRB00030471 |
|
March 2015 |
August 2020 |
August 2025 |
July 30, 2014 |
October 12, 2018 |
|
- Sibley Memorial Hospital
Washington, District of Columbia, United States - University of Chicago Medical Center
Chicago, Illinois, United States - Indiana University
Lafayette, Indiana, United States - (and 6 more...)
|
|
| 95 |
NCT03191942 |
Recruiting |
Variation of Orthokeratology Lens Treatment Zone (VOLTZ) Study |
|
- Device: Modified ortho-k lenses
- Device: Ortho-k lenses
|
Interventional
|
Not Applicable |
- The Hong Kong Polytechnic University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in axial length before and after two years of lens wear
- Treatment zone characteristics
- Pupil sizes
- Choroidal thickness
|
60 |
All |
6 Years to 11 Years (Child) |
NCT03191942 |
HSEARS20170118004 |
|
June 14, 2017 |
June 2020 |
August 2020 |
June 19, 2017 |
June 21, 2017 |
|
- School of Optometry, The Hong Kong Polytechnic University
Kowloon, Hong Kong - School of Optometry
Kowloon, Hong Kong
|
|
| 96 |
NCT00294476 |
Unknown † |
IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma |
- Cancer of Colon
- Malignant Melanoma
- Urologic Cancer
|
- Drug: IVIG
- Procedure: Biological Therapy
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 1. Tumor response is measured at baseline and evaluated every 3 treatment cycles (9 weeks) by RECIST(CT or MRI measurements), Time to Progression
- and Serum tumor markers as appropriate CEA, PSA. Additionally, ECOG performance status is evaluated before each treatment cycle
- Secondary efficacy measurements: Overall survival, Karnofsky Performance Status is evaluated at baseline and before each treatment cycle and Quality of life questionnaires is completed and evaluated at baseline and every 3 treatment cycles (9 weeks)
- Safety assessments include Adverse events and laboratory values which are measured and evaluated before every treatment cycle
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT00294476 |
GCan-01 |
|
July 2005 |
|
|
February 22, 2006 |
October 12, 2006 |
|
- Ella Institute, Oncology institute, Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel - Oncology Institute, Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel - Oncology institute, Shaare Zedek Medical Center
Jerusalem, Israel
|
|
| 97 |
NCT02251288 |
Active, not recruiting |
A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine |
- Avian Influenza
- Immunisation
|
- Biological: Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca
- Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013
- Drug: MF59 adjuvant
|
Interventional
|
Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA)
- Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Group 2
- Geometric mean titers determined by neuraminidase inhibiting antibody by enzyme-linked lectin assay (ELLA) for Group 3
- (and 64 more...)
|
62 |
All |
18 Years to 47 Years (Adult) |
NCT02251288 |
13-0087
HHSN272201200005C |
|
July 14, 2015 |
October 23, 2018 |
October 23, 2018 |
September 29, 2014 |
October 29, 2018 |
|
- University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, United States
|
|
| 98 |
NCT00169884 |
Unknown † |
The Efficacy of a Cognitive-Behavioural Intervention in Deliberate Self-Harm Patients |
|
- Behavioral: cognitive-behavioural therapy
|
Interventional
|
Phase 2 |
- Leiden University Medical Center
- ZonMw: The Netherlands Organisation for Health Research and Development
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Treatment
|
- repetition of DSH
- psychiatric diagnosis, depression, hopelessness, suicidal intent, suicidal cognitions, self-concept, (cognitive) coping, emotion regulation difficulties, impulsivity, social support, hostility, personality disorder related beliefs and attachment style.
|
120 |
All |
15 Years to 35 Years (Child, Adult) |
NCT00169884 |
2100.0068 |
|
March 2002 |
|
March 2007 |
September 15, 2005 |
February 1, 2006 |
|
- Leiden University Medical Center
Leiden, Netherlands - MCH Westeinde
The Hague, Netherlands
|
|
| 99 |
NCT01600612 |
Unknown † |
Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial |
|
- Drug: carbetocin
- Drug: misopristol
- Drug: oxytocin
|
Interventional
|
Not Applicable |
- Sohag University
- Al-Azhar University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- control of postpartum hemorrhage
- time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications.
|
300 |
Female |
Child, Adult, Older Adult |
NCT01600612 |
salah-1 |
|
September 2012 |
June 2013 |
July 2013 |
May 17, 2012 |
May 31, 2013 |
|
- Sohag university
Sohag, Egypt
|
|
| 100 |
NCT01489813 |
Recruiting |
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment |
|
- Drug: Genistein
- Drug: Sugar pill
|
Interventional
|
Phase 2 |
- Emory University
- DSM Nutritional Products, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in severity of urinary symptoms as determined by the IPSS questionnaire score.
- Rate of cancer recurrence determined at 10-week biopsy.
|
44 |
All |
18 Years and older (Adult, Older Adult) |
NCT01489813 |
IRB00050273
EU2010-11 |
|
May 19, 2017 |
May 2020 |
May 2022 |
December 12, 2011 |
November 14, 2018 |
|
- Emory University Department of Urology
Atlanta, Georgia, United States - Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
|
|
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