Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

Inclusion criteria

• women in good general health with regular, ovulatory menstrual cycles
• age 18-35
• not pregnant
• not sexually active or reliably use barrier methods of contraception
• normal liver and renal functions and normal laboratory exams

Exclusion criteria

• pregnant or breastfeeding
• oral contraception, IUD or other hormonal treatment
• use of agents known to induce hepatic P450
• cardiovascular disorder
• hepatic, renal, or gastrointestinal disorder
• metrorrhagia
• abnormal transvaginal ultrasound (at baseline)
• history of abnormal endometrial biopsy,
• cancer
• depression
• mental illness
• epilepsy
• migraines
• abnormal Pap Smear requiring further exploratory examination
• anovulatory cycle before treatment
• extreme overweight or underweight (body mass index < 16 ou >28)
• subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
• use of narcotics
• more than 10 cigarettes per day, more than 2 glasses of wine/beer per day
• surgical procedures planned in the 6 months following screening visit