Esmya (ulipristal acetate) / Perrigo Company, HRA Pharma, Gedeon Richter, AbbVie, ASKA Pharma  >>  Phase 3
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17 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Esmya (ulipristal acetate) / ASKA Pharma, Gedeon Richter, AbbVie, Perrigo Company
NCT00411684: Safety and Efficacy of CDB-2914 for Emergency Contraception

Completed
3
1623
US
CDB-2914
HRA Pharma
Emergency Contraception
04/08
06/09
NCT00551616 / 2006-003387-55: Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

Completed
3
2221
Europe, US
CDB-2914, Levonorgestrel
HRA Pharma
Contraception
04/09
04/09
PEARLII, NCT00740831 / 2008-001805-40: PGL4001 Versus GnRH-agonist in Uterine Myomas

Checkmark P3 Data - PEARL II
May 2012 - May 2012: P3 Data - PEARL II
Checkmark P3 Data: PEARL II
Feb 2012 - Feb 2012: P3 Data: PEARL II
Completed
3
301
Europe, RoW
PGL4001, Ulipristal acetate, leuprorelin, GnRH-agonist
PregLem SA
Uterine Myomas
01/10
06/10
PEARLI, NCT00755755 / 2008-001804-22: PGL4001 Versus Placebo in Uterine Myomas

Checkmark PEARL I
Jan 2014 - Jan 2014: PEARL I
Checkmark P3 Data: PEARL I
Feb 2012 - Feb 2012: P3 Data: PEARL I
Completed
3
241
Europe, RoW
PGL4001 (ulipristal) and iron, Ulipristal acetate, PGL4001 matching placebo and iron, Placebo of ulipristal
PregLem SA
Uterine Myomas
03/10
08/10
PEARLIII, NCT01156857 / 2010-018999-25: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Completed
3
209
Europe
PGL4001, placebo, Ulipristal acetate, PGL4001, progestin
PregLem SA
Uterine Fibroids
11/11
02/12
PEARLIII-extension, NCT01252069 / 2010-019497-32: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata ( Study)

Completed
3
132
Europe
PGL4001, placebo, drug free period, Ulipristal acetate, PGL4001, progestin, drug free period
PregLem SA
Uterine Fibroids
08/13
01/14
NCT01553123: Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

Withdrawn
3
0
US
Ulipristal Acetate, UPA, Iron
Watson Pharmaceuticals
Leiomyomas
11/13
12/13
PEARLIV, NCT01629563 / 2012-000036-26: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Checkmark
Oct 2015 - Oct 2015: 
Completed
3
451
Europe, RoW
PGL4001 5 mg, Ulipristal Acetate, Esmya, PGL4001 10 mg, Ulipristal Acetate
PregLem SA
Uterine Fibroids
01/15
01/15
PEARLext2, NCT01642472 / 2012-001465-33: PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Checkmark
Mar 2017 - Mar 2017: 
Checkmark Completion of enrollment of P3 trial in uterine fibroids
Jan 2016 - Jan 2016: Completion of enrollment of P3 trial in uterine fibroids
Completed
3
64
Europe
Ulipristal Acetate - open label, PGL4001
PregLem SA
Uterine Fibroids
03/15
04/15
NCT02147197: A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Checkmark Venus I and II trials in uterine fibroids
Dec 2016 - Dec 2016: Venus I and II trials in uterine fibroids
Checkmark Venus I trial for uterine leiomyomas
May 2016 - May 2016: Venus I trial for uterine leiomyomas
Completed
3
157
US
Ulipristal acetate (UPA), Placebo
Allergan
Leiomyoma, Uterine Hemorrhage
03/16
03/16
NCT02425878 / 2014-000964-16: Ulipristal Acetate 10 mg and Asisted Reproduction

Terminated
3
2
Europe
Ulipristal Acetate, Placebo
Instituto Valenciano de Infertilidad, IVI VALENCIA
Intramural Fibroids, Uterine Fibroids
05/16
05/16
2014-003408-65: Comparison of drug ulipristal acetate with existing treatment of levonorgestrel-releasing intra-uterine system.

Ongoing
3
220
Europe
Ulipristal acetate, Levonorgestrel-releasing intra-uterine system, Tablet, , Esmya, Mirena
University of Edinburgh, NHS Lothian
Heavy menstrual bleeding, Heavy menstrual bleeding, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
 
 
NCT02147158: A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Checkmark Venus I and II trials in uterine fibroids
Dec 2016 - Dec 2016: Venus I and II trials in uterine fibroids
Completed
3
432
Canada, US
Ulipristal acetate (UPA), Placebo
Allergan
Leiomyoma, Uterine Hemorrhage
11/16
11/16
INTERRUPT, NCT03118297: Intervention to End Recurrent Unscheduled Bleeding Trial

Completed
3
65
US
Ulipristal Acetate, Placebo oral capsule
Washington University School of Medicine
Contraception, Bleeding
01/18
01/18
LIBRella, NCT03208985: A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions

Completed
3
1270
US
Use Phase (Ulipristal Acetate, 30 mg)
HRA Pharma
Emergency Contraception
06/18
06/18
NCT06727734: Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Not yet recruiting
3
980
NA
Levonorgestrel, Anlitin, Piroxicam, CP-Pirox, Ulipristal Acetate, Ella, Placebo - LNG, Placebo - Piroxicam, Placebo - UPA
The University of Hong Kong, The Family Planning Association of Hong Kong
Contraception
09/27
10/27
NCT00271583: Efficacy Trial of CDB 2914 for Emergency Contraception

Completed
2/3
1672
US
CDB-2914, levonorgestrel
University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Emergency Contraception
 
09/01

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