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This version published online on January 25, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2004-0895
A more recent version of this article appeared on April 1, 2005
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Submitted on May 12, 2004
Accepted on January 14, 2005

A Multicenter Phase IIb Study of a novel combination of intramuscular Androgen (Testosterone Decanoate) and oral Progestogen (Etonogestrel) for Male Hormonal Contraception

CATHY J. HAY*, BRIAN M. BRADY, MICHAEL ZITZMANN, KAAN OSMANAGAOGLU, PASI POLLANEN, DAN APTER, FREDERICK C. W. WU, RICHARD A. ANDERSON, EBERHARD NIESCHLAG, PAUL DEVROEY, ILPO HUHTANIEMI, and WENDY M. KERSEMAEKERS

Department of Endocrinology, Manchester Royal Infirmary, University of Manchester, United Kingdom M13 9WL; Medical Research Council Human Reproductive Sciences Unit (R.A.A), Centre for Reproductive Biology, University of Edinburgh, Edinburgh EH3 9ET; Institute of Reproductive Medicine of the University of Münster, Germany; Centre for Reproductive Medicine, University Hospital, Dutch-speaking Brussels Free University (Vrije Universiteit Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium; Department of Physiology, Institute of Biomedicine, University of Turku, 20520 Turku, Finland; The Sexual Health Clinic, Family Federation of Finland, PO Box 849, 00101 Helsinki, Finland; Clinical Development Department, N.V. Organon, Oss, The Netherlands

* To whom correspondence should be addressed. E-mail: cathyhay{at}doctors.org.uk.

The effect of a novel combination of oral etonogestrel (ENG) and intramuscular testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300ìg ENG daily and 400mg TD every 4 (n=55) or 6 (n=57) weeks for 48 weeks. At week 48 all men except one in the 6-week group suppressed sperm concentration to 1 million (M)/mL. Faster suppression occurred in the 4-week group. Gonadotropins were suppressed in both groups and most consistently in the 4-week group. During treatment, trough testosterone (T) levels increased into the normal range in the 4-week group but remained just below normal in the 6-week group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew due to an adverse event with those possibly related to the study medication reported more frequently in the 6-week group (9 vs. 1). In conclusion the combination of 300µg ENG with 400mg TD every 4 weeks was superior in terms of efficacy, hormone profiles and safety. This represents a promising approach to male hormonal contraception.
Key words: Etonogestrel • male • testosterone decanoate • contraception • spermatogenesis




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