A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Summary

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Timeline

Start

2014-01-29

Primary completion

2016-11-24

Completion

2016-11-24

Outcome

Met primary endpoint

paper Treatment with 5 mg or 10 mg ulipristal was superior to placebo in achieving amenorrhea PMID 30303900 ↗

paper most women who achieved amenorrhea did so within 10 days (time to amenorrhea, P<.001 for each dose). PMID 30303900 ↗

Publications

• Coyne KS, Harrington A, Currie BM, Chen J, Gillard P, Spies JB. Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL). J Patient Rep Outcomes. 2019 Aug 23;3(1):57. doi: 10.1186/s41687-019-0146-x.
• Lukes AS, Soper D, Harrington A, Sniukiene V, Mo Y, Gillard P, Shulman L. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):869-878. doi: 10.1097/AOG.0000000000003211.
• Liu JH, Soper D, Lukes A, Gee P, Kimble T, Kroll R, Mallick M, Chan A, Gillard P, Harrington A, Sniukiene V, Shulman LP. Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1241-1251. doi: 10.1097/AOG.0000000000002942.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ulipristal acetate (UPA)	Unknown	5 mg	Oral
Subject	Ulipristal acetate (UPA)	Unknown	10 mg	Oral

Indications