This Article Full Text Full Text (PDF) All Versions of this Article: 92/9/3582    most recent Author Manuscript (PDF) Submit a related Letter to the Editor Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Chabbert-Buffet, N. Search for Related Content PubMed PubMed Citation Articles by Chabbert-Buffet, N. Related Collections Female Endocrinology Neuroendocrinology and Pituitary

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

Department of Obstetrics, Gynecology, Reproductive Medicine, and Public Health (N.C.-B.), Hospital Tenon, 75020 Paris, France; Equipe d’Accueil 1533 (N.C.-B., P.B.), Institut Fédératif de Recherche and University Pierre and Marie Curie, 75005 Paris, France; Department of Obstetrics and Gynecology (A.P.-K.), University of Liege, 4000 Liege, Belgium; and Endocrinology Unit (P.B.), Hospital Saint Antoine, 75012 Paris, France

Address all correspondence and requests for reprints to: Nathalie Chabbert-Buffet, Department of Obstetrics and Gynecology, Hospital Tenon, 4 Rue de la Chine, 75020 Paris, France. E-mail: nathalie.chabbert-buffet{at}tnn.aphp.fr.

Context: Progestin-only pills, the main hormonal alternative to ethinyl estradiol-containing pills in women bearing vascular risk factors, are poorly tolerated due to irregular bleeding. In contrast, progesterone receptor modulators can inhibit ovulation, alter endometrial receptivity, and improve cycle control.

Objective: We evaluated the effects of a new progesterone receptor modulator, VA2914, administered continuously for 3 months, on ovulation and endometrial maturation.

Design, Settings, and Patients: Forty-six normal women were included in a prospective, placebo-controlled, randomized trial, conducted in four referral centers.

Intervention: VA2914 (2.5, 5, or 10 mg/d) was administered continuously for 84 d. Pelvic ultrasound (treatment d 67 and 77), hormonal monitoring (FSH, LH, estradiol, and progesterone on treatment d 59, 63, 67, 70, 74, 77, 80, and 84), and endometrial biopsy (treatment d 77) were performed.

Main Outcome Measure: Ovulation inhibition was assessed by the absence of progesterone values above 3 ng/ml at any time during treatment month 3.

Results: Anovulation was observed in 81.8% women in the 5-mg group and 80% in the 10-mg group, and amenorrhea occurred in 81.2 and 90% of cases in the 5- and 10-mg groups. We did not detect any cases of endometrial hyperplasia despite estradiol levels that remained in the physiological follicular phase range throughout treatment cycle 3.

Conclusions: Continuous low-dose VA2914 can induce amenorrhea and inhibit ovulation without down-regulating estradiol levels or inducing endometrial hyperplasia in normal women. Long-term studies with a larger population are required to confirm the contraceptive efficacy of this regimen.

This article has been cited by other articles:

				R. L. Barbieri Update in Female Reproduction: A Life-Cycle Approach J. Clin. Endocrinol. Metab., July 1, 2008; 93(7): 2439 - 2446. [Abstract] [Full Text] [PDF]

				E. D. Levens, C. Potlog-Nahari, A. Y. Armstrong, R. Wesley, A. Premkumar, D. L. Blithe, W. Blocker, and L. K. Nieman CDB-2914 for Uterine Leiomyomata Treatment: A Randomized Controlled Trial Obstet. Gynecol., May 1, 2008; 111(5): 1129 - 1136. [Abstract] [Full Text] [PDF]