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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR ULIPRISTAL ACETATE

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505(b)(2) Clinical Trials for ulipristal acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

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Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03208985 ↗	A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions	Completed	HRA Pharma	Phase 3	2017-05-23	This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.
>Trial Type	>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

All Clinical Trials for ulipristal acetate

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00290251 ↗	Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914	Completed	HRA Pharma	Phase 2	2006-02-01	This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
NCT00290251 ↗	Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2006-02-01	This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
NCT00740831 ↗	PGL4001 Versus GnRH-agonist in Uterine Myomas	Completed	PregLem SA	Phase 3	2008-08-01	This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
NCT00755755 ↗	PGL4001 Versus Placebo in Uterine Myomas	Completed	PregLem SA	Phase 3	2008-10-01	This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
NCT01107106 ↗	Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women	Completed	HRA Pharma		2010-05-01	The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for ulipristal acetate

Condition Name

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Condition Name for ulipristal acetate
Intervention	Trials
Contraception	13
Uterine Fibroids	6
Leiomyoma	4
Fibroid	4
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Condition MeSH

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Condition MeSH for ulipristal acetate
Intervention	Trials
Leiomyoma	22
Myofibroma	21
Emergencies	10
Hemorrhage	8
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Clinical Trial Locations for ulipristal acetate

Trials by Country

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Trials by Country for ulipristal acetate
Location	Trials
United States	130
Italy	7
United Kingdom	5
Spain	5
Belgium	5
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Trials by US State

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Trials by US State for ulipristal acetate
Location	Trials
California	9
Colorado	9
New York	8
Oregon	8
Illinois	7
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Clinical Trial Progress for ulipristal acetate

Clinical Trial Phase

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Clinical Trial Phase for ulipristal acetate
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	12
Phase 2	8
[disabled in preview]	8
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Clinical Trial Status

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Clinical Trial Status for ulipristal acetate
Clinical Trial Phase	Trials
Completed	24
Unknown status	14
Terminated	5
[disabled in preview]	8
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Clinical Trial Sponsors for ulipristal acetate

Sponsor Name

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Sponsor Name for ulipristal acetate
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	6
PregLem SA	6
University Magna Graecia	4
[disabled in preview]	8
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Sponsor Type

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Sponsor Type for ulipristal acetate
Sponsor	Trials
Other	51
Industry	21
NIH	8
[disabled in preview]	0
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