Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

June 16, 2010 updated by: HRA Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium
        • Liege University Hospital
      • Liege, Belgium
        • Sainte Rosalie Clinique
  • France
      • Clamart, France
        • Antoine Béclère Hospital
      • Paris, France
        • Saint Antoine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ovarian hormones
follicular development
endometrial histology

Secondary Outcome Measures

Outcome Measure
adverse events
laboratory parameters
menstural bleeding patterns
cervical mucus
VA2914 concentration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HRA Pharma

Investigators

  • Principal Investigator: Philippe Bouchard, MD, Saint Antoine Hospital, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

June 17, 2010

Last Update Submitted That Met QC Criteria

June 16, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2914-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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