Trials / Completed
CompletedNCT02323646
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 47 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
| DRUG | Telapristone Acetate | Telapristone acetate, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
Timeline
- Start date
- 2015-02-12
- Primary completion
- 2017-04-06
- Completion
- 2017-04-06
- First posted
- 2014-12-23
- Last updated
- 2019-06-25
- Results posted
- 2019-06-14
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02323646. Inclusion in this directory is not an endorsement.