Trial | NCT00456924  Report issue

Title

Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
Study Started
Jan 31
2004
Study Completion
Dec 31
2004
Last Update
Jun 17
2010
Estimate

Drug VA2914

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
No Results Posted