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Testosterone Undecanoate Maintains Spermatogenic Suppression Induced by Cyproterone Acetate Plus Testosterone Undecanoate in Normal Men

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

In this study we evaluated whether testosterone undecanoate (TU), alone or combined with low dose cyproterone acetate (CPA), can maintain spermatogenic suppression induced by higher doses of CPA plus TU. Twenty-four men received for 12 wk 20 mg/d CPA plus 1000 mg/6 wk TU and then 1000 mg/8 wk TU plus 20 mg/d CPA (n = 8), 2 mg/d CPA (n = 8), or plus placebo (n = 8) for 32 wk. Blood samples, physical examinations, hormones, chemistry, hematology, semen analysis, and sexual/behavioral assessments were performed throughout the study. Sperm counts decreased to less than 1 million/ml in all subjects by wk 12, and 54% of them achieved azoospermia. Suppression of sperm counts was maintained until wk 44. Serum LH and FSH levels were suppressed by wk 12 of hormone administration and remained suppressed until wk 44. No significant changes in any biochemical parameters were detected at wk 44 in any group. There was a slight increase in total prostate volume to within the normal range at wk 44 that returned to baseline 1 yr after stopping hormone administration. In conclusion, TU alone or combined with lower doses of CPA maintains sperm suppression induced by higher dose CPA plus TU for 32 wk. This prototype regimen represents a promising male contraceptive regimen.

This work was supported by the CICCR Program of the Contraceptive Research and Development Program, Eastern Virginia Medical School (Subproject CIG-97-10), I Clinic of Obstetrics and Gynecology, S. Orsola Hospital, University of Bologna, and the University of Washington, Population Center for Research in Reproduction, in association with Jenapharm GmbH & Co.

Abbreviations: CI, Confidence interval; CPA, cyproterone acetate; E2, estradiol; HDL, high-density lipoprotein; PRL, prolactin; PSA, prostate-specific antigen; T, testosterone; TE, testosterone enanthate; TU, testosterone undecanoate.

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