Study to Evaluate Menses Induction in Women Administered Proellex

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Amenorrhea

In brief

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

Key facts

Study ID

NCT00881608

Run by

Repros Therapeutics Inc.

People needed

11

Starts

2009-02-01

Expected to finish

2009-08-01

Last updated by the study team

2014-08-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advances in Health Inc. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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