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Last Updated: May 11, 2021

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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
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 Recruiting 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 >Phase >Start Date >Summary

All Clinical Trials for Ulipristal Acetate

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 N/A 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.
NCT01156857 PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata Completed PregLem SA Phase 3 2010-07-01 This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ulipristal Acetate

Condition Name

Condition Name for Ulipristal Acetate
Intervention Trials
Contraception 12
Uterine Fibroids 5
Fibroid 4
Heavy Menstrual Bleeding 3
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Condition MeSH

Condition MeSH for Ulipristal Acetate
Intervention Trials
Leiomyoma 20
Myofibroma 19
Emergencies 8
Hemorrhage 8
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Clinical Trial Locations for Ulipristal Acetate

Trials by Country

Trials by Country for Ulipristal Acetate
Location Trials
United States 116
Italy 6
Spain 5
Belgium 4
Poland 4
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Trials by US State

Trials by US State for Ulipristal Acetate
Location Trials
Colorado 8
Illinois 7
Pennsylvania 7
Oregon 7
New York 7
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Clinical Trial Progress for Ulipristal Acetate

Clinical Trial Phase

Clinical Trial Phase for Ulipristal Acetate
Clinical Trial Phase Trials
Phase 4 18
Phase 3 11
Phase 2 6
[disabled in preview] 9
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Clinical Trial Status

Clinical Trial Status for Ulipristal Acetate
Clinical Trial Phase Trials
Not yet recruiting 18
Recruiting 14
Completed 12
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Clinical Trial Sponsors for Ulipristal Acetate

Sponsor Name

Sponsor Name for Ulipristal Acetate
Sponsor Trials
PregLem SA 5
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 5
HRA Pharma 4
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Sponsor Type

Sponsor Type for Ulipristal Acetate
Sponsor Trials
Other 44
Industry 17
NIH 7
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