Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HRA Pharma
• Treatments: Progesterone

Criteria

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