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Testosterone Gel Combined with Depomedroxyprogesterone Acetate Is an Effective Male Hormonal Contraceptive Regimen and Is Not Enhanced by the Addition of a GnRH Antagonist

Department of Medicine (S.T.P., J.K.A., B.D.A., M.S.I., A.T.B., A.M.M., W.J.B.), University of Washington, Seattle, Washington 98195; and Geriatric Research, Education and Clinical Center (A.M.M.), and Department of Medicine (B.D.A., A.M.M.), Veterans Affairs Puget Sound Health Care System, Seattle, Washington 98108

Address all correspondence and requests for reprints to: Stephanie T. Page, M.D., Ph.D., P.O. Box 357138, 1959 NE Pacific, Seattle, Washington 98195. E-mail: page{at}u.washington.edu.

Introduction: Exogenous androgens plus progestins can be used to suppress spermatogenesis, resulting in effective male hormonal contraception; however, induction of azoospermia can require 3–6 months, and these methods require injectable or implantable androgens. We hypothesized that testosterone (T) transdermal gel (T gel) could be combined with a depot formulation of the progestin, depomedroxyprogesterone acetate (DMPA), with or without the potent GnRH antagonist, acyline, to suppress spermatogenesis conveniently, rapidly, and reversibly.

Objectives: The objectives of the study were: 1) to determine the rate of severe oligospermia (1 million sperm/ml) using T gel+DMPA; and 2) to determine whether the addition of acyline to T gel+DMPA during the first 12 wk of the regimen would accelerate and improve suppression of spermatogenesis.

Methods: Forty-four healthy men, ages 18–55 yr, were randomized to T gel (100 mg daily)+DMPA (300 mg/3 months) or acyline (300 µg/kg·2 wk x 12 wk)+T gel+DMPA. Thirty-eight men completed the 24-wk treatment protocol.

Results: All men had dramatic suppression of spermatogenesis; 90% of the subjects became severely oligospermic, a rate comparable to implantable and injectable T+progestin combinations. The addition of acyline did not significantly accelerate spermatogenic suppression or improve rates of severe oligospermia. There were no serious adverse events, and there were minimal changes in weight, serum lipids, and prostate-specific antigen.

Conclusions: The combination of T gel+DMPA is a promising new regimen in male contraception. The addition of the GnRH antagonist acyline, as part of an induction phase in a male contraception regimen, has limited clinical utility. Additional studies using T gel for male contraception are warranted.

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