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A Clinical Trial of Injectable Testosterone Undecanoate as a Potential Male Contraceptive in Normal Chinese Men¹

Department of Endocrinology, National Research Institute for Family Planning (G.-y.Z), Beijing 100081, China; Population Center for Research in Reproduction, Department of Medicine, University of Washington, (Y.-q.G., W.J.B), Seattle, Washington 98195; Jiangsu Family Planning Research Institute, (X.-h.W.) Jiangsu 210029, China; and the Department of Endocrinology, Nanjing Medical University (Y.-g.C.), Jiangsu 210029, China

Address all correspondence and requests for reprints to: William J. Bremner, M.D., Ph.D., Department of Medicine, University of Washington, Box 356420, Seattle, Washington 98195. E-mail: wbremner{at}u.washington.edu

This is a pilot dose-finding study of spermatogenic suppression using testosterone undecanoate (TU) injections alone in normal Chinese men. Thirty-two healthy men were recruited. Volunteers underwent pretreatment evaluation, then a treatment period in which group I (n = 13) received 500 mg TU, group II (n = 12) received 1000 mg TU, and group III (n = 7) received placebo, respectively, at monthly intervals during the treatment period (or until azoospermia was achieved). Thereafter, they underwent a recovery period until all parameters returned to pretreatment levels. Eleven of 12 volunteers in the 500-mg TU group, and all volunteers in the 1000-mg TU group became azoospermic. Faster suppression of spermatogenesis was achieved in the 1000-mg TU group. Serum testosterone increased significantly in the higher dose group at weeks 8 and 12, but remained within the normal range. Mean serum LH and FSH were profoundly suppressed by both doses to undetectable levels at week 16. TU injections did not cause a significant change in high density lipoprotein cholesterol levels. No serious side-effects were found. We conclude that both dosages of TU can effectively, safely, and reversibly suppress spermatogenesis in normal Chinese men.

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