Study to Evaluate Menses Induction in Women Administered Proellex

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

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

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

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