CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Proellexdrug
Likely dose
Proellex 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01187043
NCT01187043Phase 2Completed
CompareCT.gov

A Single-Blind, Placebo Run-in, Phase I/II Study Comparing Five Oral Doses of Proellex®

Repros Therapeutics Inc.·interventional·Posted Aug 23, 2010·Updated Jul 28, 2014

In Brief

A Phase 2 clinical trial evaluating Proellex for Amenorrhea. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmenorrhea
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2010
Enrollment StartAug 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.9 years ago

Interventions

Proellexdrug

1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)