NCT00456924

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
Last Updated

June 17, 2010

Status Verified

June 1, 2010

First QC Date

April 4, 2007

Last Update Submit

June 16, 2010

Conditions

ContraceptionGynecologic Diseases

Keywords

progesterone receptor modulator

Outcome Measures

Primary Outcomes (3)

  • ovarian hormones

  • follicular development

  • endometrial histology

Secondary Outcomes (5)

  • menstural bleeding patterns

  • cervical mucus

  • VA2914 concentration

  • adverse events

  • laboratory parameters

Interventions

VA2914DRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Liege University Hospital

Liège, Belgium

Location

Sainte Rosalie Clinique

Liège, Belgium

Location

Antoine Beclere Hospital

Clamart, France

Location

Saint Antoine Hospital

Paris, France

Location

Related 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, placebo-controlled trial. J Clin Endocrinol Metab. 2007 Sep;92(9):3582-9. doi: 10.1210/jc.2006-2816. Epub 2007 Jun 19.

    PMID: 17579200RESULT

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

ulipristal

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Philippe Bouchard, MD

    Saint Antoine Hospital, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2004

Last Updated

June 17, 2010

Record last verified: 2010-06

Locations

BE(2)FR(2)