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A Multicenter Phase IIb Study of a Novel Combination of Intramuscular Androgen (Testosterone Decanoate) and Oral Progestogen (Etonogestrel) for Male Hormonal Contraception

Department of Endocrinology (C.H., F.C.W.W.), Manchester Royal Infirmary, University of Manchester, Manchester M13 9WL, United Kingdom; Medical Research Council Human Reproductive Sciences Unit (B.M.B., R.A.A.), Centre for Reproductive Biology, University of Edinburgh, Edinburgh EH3 9ET, United Kingdom; Institute of Reproductive Medicine, University of Münster (M.Z., E.N.), 48129 Münster, Germany; Centre for Reproductive Medicine (K.O., P.D.), University Hospital, Dutch-Speaking Brussels Free University (Vrije Universiteit Brussel), 1090 Brussels, Belgium; Department of Physiology (P.P., I.H.), Institute of Biomedicine, University of Turku, 20520 Turku, Finland; The Sexual Health Clinic (D.A.), Family Federation of Finland, 00101 Helsinki, Finland; Clinical Development Department (W.M.K.), NV Organon, NL-5340 BH Oss, The Netherlands

Address all correspondence and requests for reprints to: Dr. Cathy Hay, Department of Endocrinology, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, United Kingdom. E-mail: cathyhay{at}doctors.org.uk.

The effect of a novel combination of oral etonogestrel (ENG) and im 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 300 µg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk 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 because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 µg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception.

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