drugset / Trial / NCT02323646
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
Timeline
- Start
- 2015-02-12
- Primary completion
- 2017-04-06
- Completion
- 2017-04-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telapristone Acetate | Other / unclassified | 6 mg | Other |
| Subject | Telapristone Acetate | Other / unclassified | 12 mg | Other |