Clinical Trial: Study to Evaluate Menses Induction in Women Administered Proellex

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex

Brief Summary: The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

Detailed Summary: The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally
Sponsor: Repros Therapeutics Inc.

Current Primary Outcome: Day of Initial Vaginal Bleeding Event Following Treatment With Proellex. [ Time Frame: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Duration of Vaginal Bleeding Following Treatment With Proellex. [ Time Frame: At least 2 days ]

Original Secondary Outcome: Same as current

Information By: Repros Therapeutics Inc.

Dates:
Date Received: April 14, 2009
Date Started: February 2009
Date Completion:
Last Updated: August 8, 2014
Last Verified: August 2014