Status:
COMPLETED
Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914
Lead Sponsor:
HRA Pharma
Conditions:
Contraception
Gynecologic Diseases
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00456924
Start Date
January 1 2004
End Date
December 1 2004
Last Update
June 17 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Liege University Hospital
Liège, Belgium
2
Sainte Rosalie Clinique
Liège, Belgium
3
Antoine Beclere Hospital
Clamart, France
4
Saint Antoine Hospital
Paris, France