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Male Hormonal Contraception: A Double-Blind, Placebo-Controlled Study

Departments of Global Clinical Development (E.Mo.), Translational Medicine (W.M.K.), and Biometrics (M.K.), NV Organon (part of Schering-Plough), 5340 BH Oss, The Netherlands; Department of Fertility Control and Hormone Therapy (J.E.), Bayer Schering Pharma AG, 13342 Berlin, Germany; The Sexual Health Clinic (D.A., L.V.), Family Federation of Finland, 00101 Helsinki, Finland; Andrology Unit (H.M.B., H.-P.G.), Department of Urology, Martin Luther University Halle-Wittenberg, 06099 Halle, Germany; Department of Endocrinology (J.B., F.C.W.), Manchester Royal Infirmary, University of Manchester, Manchester M13 9PT, United Kingdom; Centre for Neuroendocrinology (P.M.B., A.S.), Royal Free Hospital, Hampstead, London NW3 2PF, United Kingdom; Clinic Obstetrics and Gynecology (A.C., M.C.M.), University of Bologna, S. Orsola Hospital, 40138 Bologna, Italy; Nordica Fertility Clinic (L.G., S.L.), 2400 Copenhagen, Denmark; Dinox GmbH Clinical Research (D.H.-M., C.L.), 10115 Berlin, Germany; Institute of Reproductive and Developmental Biology (I.H.), Imperial College London, London SW7 2AZ United Kingdom; Department of Urology (E.L.K.), Catharina Hospital, 5623 EJ Eindhoven, Netherlands; Department of Urology (E.Me., P.F.A.M.), Radboud University Nijmegen Medical Centre, 6500 HC Nijmegen, Netherlands; Institute of Reproductive Medicine (E.N., M.Z.), University of Muenster, 48149 Muenster, Germany; and Departments of Physiology and Obstetrics and Gynecology (A.P.), University of Turku, FIN-20520 Turku, Finland

Address all correspondence and requests for reprints to: Ellen Mommers, Ph.D., Global Clinical Development Department, Organon, part of Schering-Plough, P.O. Box 20, 5340 BH Oss, The Netherlands. E-mail: ellen.mommers{at}organon.com.

Background: This study was performed to assess spermatogenesis suppression and safety of a new combination of an etonogestrel (ENG) implant combined with testosterone undecanoate (TU) injections for male contraception. This is the first large placebo-controlled study for male hormonal contraception.

Design and Study Subjects: In this double-blind, multicenter study, we randomly assigned 354 healthy men to receive either a low- or high-release ENG implant sc combined with im TU injections (750 mg every 10 or 12 wk or 1000 mg every 12 wk) or placebo implant and injections. Treatment duration was 42 or 44 wk and posttreatment follow-up at least 24 wk.

Results: Overall, spermatogenesis was suppressed to 1 million/ml or less at wk 16 in 89% of men, with approximately 94% in two high-release ENG groups. Suppression was maintained up to the end of the treatment period in 91% of men. For all men who completed the treatment period, 3% never achieved 1 million/ml or less. Median recovery time to a sperm concentration above 20 million/ml was 15 wk (mean 17 wk, 95% confidence interval 16–18 wk). Treatment was well tolerated. As compared with the placebo group, more men in the active treatment groups reported adverse events such as weight gain, mood changes, acne, sweating, or libido change. For both spermatogenesis suppression and safety, differences were small between the active treatment groups.

Conclusions: The combination of an ENG implant with TU injections is a well-tolerated male hormonal method, providing effective and reversible suppression of spermatogenesis. Although the results are good, there is still room for improvement, possibly by adjusting the dose regimen or changing the mode of application.

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