Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914 - Full Text View

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:

MedlinePlus related topics: Birth Control

Drug Information available for: Progesterone Ulipristal acetate

U.S. FDA Resources

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:

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. Epub 2007 Jun 19.

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 June 17, 2013