Comparison of Two Formulations of Proellex for Vaginal Administration

Exclusion Criteria

• •Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy
• •Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study
• •Women with abnormally high liver enzymes or liver disease. Alanine transaminase (ALT) or aspartate aminotransferase (AST) exceeding 1.5 x upper limit of normal (ULN) AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat).
• •Received an investigational drug in the 30 days prior to the screening for this study
• •Women with a history of polycystic ovary syndrome (PCOS)
• •Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study.
• •Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 6 months.
• •Has an intrauterine device (IUD) in place
• •Women currently using narcotics
• •Women currently taking spironolactone
• •Infectious disease screen is positive for HIV or Hepatitis A, B or C.
• •Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study