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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00456924
Other study ID # 2914-002
Secondary ID
Status Completed
Phase Phase 2
First received April 4, 2007
Last updated June 16, 2010
Start date January 2004
Est. completion date December 2004

Study information

Verified date June 2010
Source HRA Pharma
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
VA2914


Locations

Country Name City State
Belgium Liege University Hospital Liege
Belgium Sainte Rosalie Clinique Liege
France Antoine Beclere Hospital Clamart
France Saint Antoine Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
HRA Pharma

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

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

Outcome

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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