Clinical trial NCT00456924: Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Gynecologic Diseases
Keywords: progesterone receptor modulator
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: ovarian hormones
measure: follicular development
measure: endometrial histology
Secondary outcomes:
measure: menstural bleeding patterns
measure: cervical mucus
measure: VA2914 concentration
measure: adverse events
measure: laboratory parameters
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Liege University Hospital
city: Liege
country: Belgium
facility: Sainte Rosalie Clinique
city: Clamart
country: France
facility: Antoine Beclere Hospital
city: Paris
country: France
facility: Saint Antoine Hospital
Study officials:
affiliation: Saint Antoine Hospital, Paris, France
name: Philippe Bouchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, placebo-controlled trial. J Clin Endocrinol Metab. 2007 Sep;92(9):3582-9. doi: 10.1210/jc.2006-2816. Epub 2007 Jun 19.