drugset / Trial / NCT02147197
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
RandomizedParallel-groupQuadruple-blindTreatment
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
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 |