| 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Withdrawn |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 |
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 |
June 2018 |
September 2020 |
December 2020 |
September 28, 2017 |
February 23, 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...)
|
|
| 3 |
NCT02213081 |
Active, not recruiting |
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 |
NCT02361905 |
Recruiting |
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 |
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
- failure rate
- incidence of shortening or lengthening of the index menstrual cycle
|
700 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02517463 |
UW10-392 |
|
May 2011 |
April 2014 |
April 2014 |
August 7, 2015 |
August 7, 2015 |
|
|
|
| 6 |
NCT02587000 |
Recruiting |
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 |
Recruiting |
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 |
Recruiting |
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 Hysterectomy is Planned |
|
- Drug: Vilaprisan, BAY1002670
- Drug: Ulipristal
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Other
|
- a 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
- a 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 |
July 30, 2019 |
September 6, 2019 |
November 17, 2017 |
June 5, 2018 |
|
- Edinburgh Royal Infirmary/ NHS Lothian
Edinburgh, United Kingdom - Forth Valley Royal Hospital
Larbert, United Kingdom
|
|
| 12 |
NCT02357563 |
Recruiting |
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 |
NCT02601196 |
Not yet recruiting |
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 |
|
|
|
| 14 |
NCT03118297 |
Active, not recruiting |
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
- Bleeding cessation
- Bleeding satisfaction measured by weekly follow up surveys
- (and 2 more...)
|
65 |
Female |
18 Years to 45 Years (Adult) |
NCT03118297 |
201612002 |
INTERRUPT |
June 1, 2017 |
June 2018 |
June 2018 |
April 18, 2017 |
January 8, 2018 |
|
- Washington University School of Medicine in St. Louis
Saint Louis, Missouri, United States
|
|
| 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 |
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...)
|
289 |
Female |
18 Years to 43 Years (Adult) |
NCT03349190 |
0001 |
NACRE |
January 1, 2018 |
June 30, 2018 |
June 30, 2018 |
November 21, 2017 |
April 24, 2018 |
|
- Chu Angers
Angers, France - Chu Besancon
Besançon, France - Chu Pellegrin
Bordeaux, France - (and 12 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 |
Active, not recruiting |
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 2018 |
June 2018 |
July 6, 2017 |
May 4, 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 |
Recruiting |
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 |
Recruiting |
Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella |
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
|
100 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01569737 |
2914-012 |
ellipse II |
January 2012 |
June 2018 |
June 2018 |
April 3, 2012 |
February 16, 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 |
Recruiting |
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
|
60 |
Female |
18 Years to 35 Years (Adult) |
NCT02577601 |
OHSU IRB 11784 |
|
September 8, 2015 |
June 17, 2017 |
October 31, 2017 |
October 16, 2015 |
August 31, 2017 |
|
- 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 |
June 18, 2018 |
|
|
|
| 38 |
NCT01539720 |
Recruiting |
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
|
532 |
Female |
14 Years to 45 Years (Child, Adult) |
NCT01539720 |
201201007 |
LIFE |
December 2012 |
December 2019 |
December 2019 |
February 27, 2012 |
January 30, 2018 |
|
- Washington University 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
New |
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 |
NCT03240523 |
Recruiting |
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Compare to Ulipristal |
|
- Drug: Vilaprisan (BAY1002670)
- Other: Matching placebo to ulipristal
- Other: Matching placebo to vilaprisan
- Drug: Ulipristal (Esmya)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Amenorrhea (yes/no)
- Absence of bleeding (yes/no)
- Number of bleeding days
- (and 5 more...)
|
996 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03240523 |
15789
2016-002855-48 |
ASTEROID 5 |
July 31, 2017 |
September 28, 2021 |
September 28, 2021 |
August 7, 2017 |
June 15, 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 208 more...)
|
|
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