CLINICAL TRIALS PROFILE FOR ULIPRISTAL ACETATE
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505(b)(2) Clinical Trials for ulipristal acetate
| 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
| 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. | |
| 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. |
| NCT01252069 ↗ | PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study) | Completed | PregLem SA | Phase 3 | 2011-01-01 | This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment. This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ulipristal acetate
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