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NCT01187043 · ClinicalTrials.gov registry record · Phase 1
Determination of the Lowest, Safe and Effective Dose of Proellex
A Phase 1 study, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01187043: Completed Phase 1 study, sponsored by Repros Therapeutics.
NCT01187043 is a Phase 1 study that has completed, run by Repros Therapeutics. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01187043, a Phase 1 study, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
Primary Outcome
Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
Interventions
- DRUG Proellex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01187043 record still lists
NCT01187043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which Proellex is the first listed.
NCT01187043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01187043 about?
NCT01187043 is a clinical study titled "Determination of the Lowest, Safe and Effective Dose of Proellex". The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
What is the current status of trial NCT01187043?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-08. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01187043?
The interventions under investigation include: Proellex (DRUG).
Who is sponsoring clinical trial NCT01187043?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01187043's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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