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NCT02301897 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02301897 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 43 participants.
The verdict
NCT02301897, a Phase 2 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Telapristone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-03-16 |
| Est. Completion | 2017-06-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02301897
The ClinicalTrials.gov registry entry for NCT02301897 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02301897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02301897 about?
NCT02301897 is a clinical study titled "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". 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.
What is the current status of trial NCT02301897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2015-03-16. Estimated completion is 2017-06-02.
What interventions are being tested in trial NCT02301897?
The interventions under investigation include: Placebo (DRUG), Telapristone Acetate (DRUG).
Who is sponsoring clinical trial NCT02301897?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
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