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This version published online on August 29, 2006
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2006-1411
A more recent version of this article appeared on November 1, 2006
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Submitted on July 3, 2006
Accepted on August 18, 2006

TESTOSTERONE GEL COMBINED WITH DEPOMEDROXYPROGESTERONE ACETATE IS AN EFFECTIVE MALE HORMONAL CONTRACEPTIVE REGIMEN AND IS NOT ENHANCED BY THE ADDITION OF A GnRH ANTAGONIST

Stephanie T. Page*, John K. Amory, Bradley D. Anawalt, Michael S. Irwig, Andrew T. Brockenbrough, Alvin M. Matsumoto, and William J. Bremner

Department of Medicine, University of Washington, Seattle, WA; Geriatric Research, Education and Clinical Center and Department of Medicine, Veterans Affairs Puget Sound Health Care System

* To whom correspondence should be addressed. E-mail: page{at}u.washington.edu.

Introduction: Exogenous androgens + 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 gonadotropin-releasing hormone (GnRH) antagonist, acyline to conveniently, rapidly and reversibly suppress spermatogenesis.

Objectives: 1) Determine the rate of severe oligospermia (≤1 million sperm/ml) using T gel + DMPA. 2) Determine whether the addition of acyline to T gel+DMPA during the first 12 weeks of the regimen would accelerate and improve suppression of spermatogenesis.

Methods: Forty-four healthy men, ages 18-55 were randomized to T gel (100 mg daily)+DMPA (300 mg/3 months) or Acyline (300mcg/kg/2 weeks x 12 weeks) +Tgel+DMPA. Thirty-eight men completed the 24-week treatment protocol.

Results: All men had dramatic suppression of spermatogenesis; 90% of 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 PSA.

Conclusions: 1) The combination of T gel + DMPA is a promising new regimen male contraception. 2) 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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