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

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

2014-03-31

Primary completion

2016-03-29

Completion

2016-03-29

Outcome

Met primary endpoint

paper Time to amenorrhea was shorter for both ulipristal doses compared with placebo (P<.001) PMID 29420395 ↗

paper patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 1 of 56 (1.8% [97.5% CI 0.0-10.9]) placebo-treated patients (both P<.001). PMID 29420395 ↗

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.
• Simon JA, Catherino W, Segars JH, Blakesley RE, Chan A, Sniukiene V, Al-Hendy A. Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Mar;131(3):431-439. doi: 10.1097/AOG.0000000000002462.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ulipristal Acetate	Unknown	5 mg	Oral
Subject	Ulipristal Acetate	Unknown	10 mg	Oral

Indications