Study to Evaluate Menses Induction in Women Administered Proellex

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

Inclusion Criteria:

• Clinical laboratory tests within normal ranges

• A normal menstrual period of 26-30 days

• Desiring not to become pregnant

• Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

• Post-menopausal status

• Aamenorrhea or dysfunctional uterine bleeding

• Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile

• Subjects with a Body Mass Index (BMI) below 18 or over 39