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Twenty-One Day Administration of Dienogest Reversibly Suppresses Gonadotropins and Testosterone in Normal Men

Clinic of Obstetrics and Gynecology (M.C.M., A.C., C.F.) and Department of Internal Medicine and Gastroenterology (A.M.M.-L.), S. Orsola Hospital; Department of Urology, Malpighi Hospital (A.B.); and University of Bologna, 40138 Bologna, Italy; Department of Medicine, University of Washington (W.J.B.), Seattle, Washington 98108; and Jenapharm (D.H., G.K.), Jena D-07745, Germany

Address all correspondence and requests for reprints to: M. Cristina Meriggiola, M.D., Ph.D., Department of Obstetrics and Gynecology, S. Orsola Hospital, Via Massarenti 13, 40138 Bologna, Italy. E-mail: . crismeri{at}med.unibo.it

Abstract

Androgen-progestin combinations are promising male contraceptive regimens. Optimization of these regimens includes the development of new progestins with more favorable biological properties. In this context we tested the effects of the progestin dienogest (DNG) on reproductive hormones and metabolic parameters in men.

After a 3-wk control period, 25 men were randomly assigned to receive daily doses of 2, 5, or 10 mg DNG or placebo and 10 mg cyproterone acetate for 21 d (n = 5 subjects/group). Subjects were followed for 2 wk after cessation of hormone administration. Weekly blood samples, physical examinations, hormone and chemistry measurements, semen analysis, and sexual/behavioral assessments were performed. These parameters were compared among study groups and within each group at different time points throughout the study periods.

DNG and cyproterone acetate administration resulted in profound suppression of gonadotropins and T with no change in SHBG levels. No adverse effects were detected in any subject. Hormone levels returned to baseline after stopping hormone intake.

DNG is a potent suppressor of gonadotropins and T in men and does not induce adverse effects over a 21-d administration. DNG is a promising progestin to be used in clinical trials for male contraception.

This article has been cited by other articles:

				S. T. Page, J. K. Amory, and W. J. Bremner Advances in Male Contraception Endocr. Rev., June 1, 2008; 29(4): 465 - 493. [Abstract] [Full Text] [PDF]

				M. C. Meriggiola, T. M.M. Farley, and M. T. Mbizvo A Review of Androgen-Progestin Regimens for Male Contraception J Androl, July 1, 2003; 24(4): 466 - 483. [Full Text] [PDF]