| 1 |
NCT03802149 |
Not yet recruiting |
Ulipristal Acetate for Cervical Preparation |
|
|
Interventional
|
Early Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Adequacy of cervical dilation
- Need for additional mechanical dilation
- Total procedure time
- (and 4 more...)
|
25 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03802149 |
IRB-48756 |
U-Prep |
February 2019 |
February 2020 |
February 2020 |
January 14, 2019 |
January 15, 2019 |
|
|
|
| 2 |
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Withdrawn |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
|
|
| 3 |
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
|
|
| 4 |
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...)
|
|
| 5 |
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
|
|
| 6 |
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 |
|
|
| 7 |
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
|
|
| 8 |
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
|
|
| 9 |
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
|
|
| 10 |
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
|
|
| 11 |
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...)
|
|
| 12 |
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 |
February 5, 2019 |
|
- Edinburgh Royal Infirmary/ NHS Lothian
Edinburgh, United Kingdom - Forth Valley Royal Hospital
Larbert, United Kingdom
|
|
| 13 |
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
|
|
| 14 |
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
|
|
| 15 |
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 |
|
|
|
| 16 |
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
|
|
| 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 |
NCT03349190 |
Completed |
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 |
January 8, 2019 |
November 21, 2017 |
January 9, 2019 |
|
- Chu Angers
Angers, France - Chu Besancon
Besançon, France - Chu Pellegrin
Bordeaux, France - (and 20 more...)
|
|
| 19 |
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
|
|
| 20 |
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...)
|
|
| 21 |
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...)
|
|
| 22 |
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
|
|
| 23 |
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
|
|
| 24 |
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 |
|
|
|
| 25 |
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...)
|
|
| 26 |
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...)
|
|
| 27 |
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
|
|
| 28 |
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...)
|
|
| 29 |
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...)
|
|
| 30 |
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
|
|
| 31 |
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 |
|
|
|
| 32 |
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
|
|
| 33 |
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
|
|
| 34 |
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...)
|
|
| 35 |
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
|
|
| 36 |
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
|
|
| 37 |
NCT02577601 |
Completed
Has Results |
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
|
- Number of Participants With Follicle Rupture
|
36 |
Female |
18 Years to 35 Years (Adult) |
NCT02577601 |
OHSU IRB 11784 |
|
September 8, 2015 |
June 17, 2017 |
June 17, 2017 |
October 16, 2015 |
December 31, 2018 |
December 31, 2018 |
- Oregon Health & Science University
Portland, Oregon, United States
|
|
| 38 |
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 |
February 15, 2019 |
|
|
|
| 39 |
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
|
|
| 40 |
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
|
|
| 41 |
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...)
|
|
| 42 |
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
|
|
| 43 |
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...)
|
|
| 44 |
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 |
|
|
|
| 45 |
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
|
|
| 46 |
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...)
|
|
| 47 |
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
|
|
| 48 |
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
|
|
| 49 |
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
|
|
| 50 |
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...)
|
|
| 51 |
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
|
|
| 52 |
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 |
February 15, 2019 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 53 |
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...)
|
|
| 54 |
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...)
|
|
| 55 |
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
|
|
| 56 |
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...)
|
|
| 57 |
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
|
|
| 58 |
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...)
|
|
| 59 |
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
|
|
| 60 |
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
|
|
| 61 |
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...)
|
|
| 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 |
NCT03829696 |
Not yet recruiting
New |
Advance Provision of Medication Abortion |
|
- Drug: Mifeprex® (Mifepristone 200 mg)
- Drug: Misoprostol 800 mcg
- Drug: ella® (ulipristal acetate emergency contraception 30 mg)
- Diagnostic Test: AccuHome® Pregnancy OTC Test
|
Interventional
|
Phase 4 |
- University of California, San Francisco
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion of participants satisfied with the advance provision model
- Proportion of participants who are confident that they could use the abortion pills correctly if they got pregnant and decided to have an abortion using the advance provision model
- Proportion of participants who would recommend the advance provision model to a friend
- (and 5 more...)
|
50 |
Female |
18 Years to 40 Years (Adult) |
NCT03829696 |
A128753_02 |
|
May 2019 |
April 2020 |
April 2020 |
February 4, 2019 |
February 4, 2019 |
|
|
|
| 70 |
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
|
|
| 71 |
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...)
|
|
| 72 |
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
|
|
| 73 |
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
|
|
| 74 |
NCT03240523 |
Active, not recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids |
|
- 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 |
February 5, 2019 |
|
- 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 201 more...)
|
|
| 75 |
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
|
|
| 76 |
NCT03774368 |
Recruiting |
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 15, 2019 |
December 31, 2019 |
December 31, 2019 |
December 13, 2018 |
January 16, 2019 |
|
- PPLM
Boston, Massachusetts, United States
|
|
| 77 |
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
|
|
| 78 |
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...)
|
|
| 79 |
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...)
|
|
| 80 |
NCT03604185 |
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 |
February 8, 2019 |
|
- Ryerson University
Toronto, Ontario, Canada
|
|
| 81 |
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
|
|
| 82 |
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...)
|
|
| 83 |
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
|
|
| 84 |
NCT03796832 |
Not yet recruiting |
Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial) |
|
- Device: Flat Flexible Shoes
- Device: Stable Supportive Shoes
- Other: Exercise Therapy
|
Interventional
|
Not Applicable |
- University Ghent
- Universiteit Antwerpen
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in severity of knee pain on walking
- Severity of intercondylar synovitis
- Severity of whole knee effusion
- (and 9 more...)
|
106 |
All |
50 Years and older (Adult, Older Adult) |
NCT03796832 |
B670201835057
G013318N
U1111-1225-9954 |
FiREwORK |
February 1, 2019 |
June 30, 2021 |
December 31, 2021 |
January 8, 2019 |
January 8, 2019 |
|
- Ghent University, Department of Rehabilitation Sciences
Ghent, Belgium
|
|
| 85 |
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
|
|
| 86 |
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
|
|
| 87 |
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
|
|
| 88 |
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
|
|
| 89 |
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
|
|
| 90 |
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
|
|
| 91 |
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 |
December 21, 2018 |
|
- Sheba Medical Center
Tel HaShomer, Israel
|
|
| 92 |
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 |
|
|
|
| 93 |
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
|
|
| 94 |
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
|
|
| 95 |
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...)
|
|
| 96 |
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
|
|
| 97 |
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...)
|
|
| 98 |
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
|
|
| 99 |
NCT02251288 |
Completed |
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 |
|
May 18, 2015 |
August 17, 2018 |
August 17, 2018 |
September 29, 2014 |
February 15, 2019 |
|
- University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, United States
|
|
| 100 |
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
|
|
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