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Hum. Reprod. Advance Access originally published online on September 19, 2005
Human Reproduction 2006 21(1):285-294; doi:10.1093/humrep/dei300
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org

A multicentre study investigating subcutaneous etonogestrel implants with injectable testosterone decanoate as a potential long-acting male contraceptive

B.M. Brady1,8, J.K. Amory2, A. Perheentupa3, M. Zitzmann4, C.J. Hay5, D. Apter6, R.A. Anderson1, W.J. Bremner2, P. Pollanen3, E. Nieschlag4, F.C.W. Wu5 and W.M. Kersemaekers7

1 Centre for Reproductive Biology, University of Edinburgh, Edinburgh EH16 4TJ, UK, 2 Department of Medicine, Centre for Research in Reproduction and Contraception, University of Washington, Seattle, WA, USA, 3 Department of Physiology and Obstetrics and Gynaecology, Institute of Biomedicine, University of Turku, Turku, Finland, 4 Institute of Reproductive Medicine of the University of Muenster, Muenster, Germany, 5 Department of Endocrinology, Manchester Royal Infirmary, University of Manchester, Manchester, UK, 6 The Sexual Health Clinic, Family Federation of Finland, Helsinki, Finland and 7 Clinical Development Department, N.V. Organon, Oss, The Netherlands

8 To whom correspondence should be addressed. E-mail: brian.brady{at}luht.scot.nhs.uk

BACKGROUND: The combination of etonogestrel implants with injectable testosterone decanoate was investigated as a potential male contraceptive. METHODS: One hundred and thirty subjects were randomly assigned to three treatment groups, all receiving two etonogestrel rods (204 mg etonogestrel) and 400 mg testosterone decanoate either every 4 weeks (group I, n = 42), or every 6 weeks (group II, n = 51) or 600 mg testosterone decanoate every 6 weeks (group III, n = 37) for a treatment period of 48 weeks. RESULTS: One hundred and ten men completed 48 weeks of treatment. Sperm concentrations of <1 3 106/ml were achieved in 90% (group I), 82% (group II) and 89% (group III) of subjects by week 24. Suppression was slower in group II, which also demonstrated more frequent escape from gonadotrophin suppression than groups I and III. Peak testosterone concentrations remained in the normal range throughout in all groups. Mean trough testosterone concentrations were initially subphysiological but increased into the normal range during treatment. Mean haemoglobin levels increased in group I, and a non-significant increase in weight and decline in high-density lipoprotein cholesterol was observed in all groups. Fourteen subjects discontinued treatment due to adverse events. CONCLUSIONS: Subcutaneous etonogestrel implants in combination with injectable testosterone decanoate resulted in profound suppression of spermatogenesis that could be maintained for up to 1 year. Efficacy of suppression was less in group II, probably due to inadequate testosterone dosage. This combination has potential as a long-acting male hormonal contraceptive.

Key words: etonogestrel/gestogen/male contraceptive/spermatogenesis/testosterone decanoate

Submitted December 18, 2004; resubmitted May 24, 2005; ; accepted August 16, 2005
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