Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

HRA Pharma

Status and phase

Completed

Phase 2

Conditions

Gynecologic Diseases

Contraception

Treatments

Drug: VA2914

Study type

Interventional

Funder types

Industry

Identifiers

NCT00456924

2914-002

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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