Contraception Clinical Trial
Official title:
Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Liege University Hospital | Liege | |
Belgium | Sainte Rosalie Clinique | Liege | |
France | Antoine Beclere Hospital | Clamart | |
France | Saint Antoine Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
HRA Pharma |
Belgium, France,
Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P; VA2914 Study Group. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, pla — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ovarian hormones | |||
Primary | follicular development | |||
Primary | endometrial histology | |||
Secondary | menstural bleeding patterns | |||
Secondary | cervical mucus | |||
Secondary | VA2914 concentration | |||
Secondary | adverse events | |||
Secondary | laboratory parameters |
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