drugset / Trial / NCT02301897
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to determine the safety and efficacy of two oral 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
- 2015-03-16
- Primary completion
- 2017-06-02
- Completion
- 2017-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telapristone Acetate | Other / unclassified | 6 mg | Oral |
| Subject | Telapristone Acetate | Other / unclassified | 12 mg | Oral |