Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00456924
• Date of registration: 04/04/2007
• Prospective Registration: No
• Primary sponsor: HRA Pharma
• Public title: Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914
• Scientific 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
• Date of first enrolment: January 2004
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00456924
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, France

Contacts

• Name: Philippe Bouchard, MD
• Affiliation: Saint Antoine Hospital, Paris, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Gynecologic Diseases

Contraception

Intervention(s)

Drug: VA2914

Primary Outcome(s)

follicular development

endometrial histology

ovarian hormones

Secondary Outcome(s)

VA2914 concentration

adverse events

laboratory parameters

cervical mucus

menstural bleeding patterns

Secondary ID(s)

2914-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors