Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456924
• Other study ID #: 2914-002
• 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
• 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

Related Conditions & MeSH terms

• Contraception
• Genital Diseases, Female
• Gynecologic Diseases

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