Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

This study has been completed.
Sponsor:
Information provided by:
HRA Pharma
ClinicalTrials.gov Identifier:
NCT00456924
First received: April 4, 2007
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Contraception
Gynecologic Diseases
Drug: VA2914
Phase 2

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

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • ovarian hormones
  • follicular development
  • endometrial histology

Secondary Outcome Measures:
  • menstural bleeding patterns
  • cervical mucus
  • VA2914 concentration
  • adverse events
  • laboratory parameters

Estimated Enrollment: 48
Study Start Date: January 2004
Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456924

Locations
Belgium
Liege University Hospital
Liege, Belgium
Sainte Rosalie Clinique
Liege, Belgium
France
Antoine Beclere Hospital
Clamart, France
Saint Antoine Hospital
Paris, France
Sponsors and Collaborators
HRA Pharma
Investigators
Principal Investigator: Philippe Bouchard, MD Saint Antoine Hospital, Paris, France
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00456924     History of Changes
Other Study ID Numbers: 2914-002
Study First Received: April 4, 2007
Last Updated: June 16, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by HRA Pharma:
progesterone receptor modulator

Additional relevant MeSH terms:
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014