title: Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  The objectives of the study were: 1) to determine the rate of severe oligospermia (< or = 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 microg/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.
authors.affiliation: Department of Medicine, University of Washington, Seattle, Washington 98195, USA. page@u.washington.edu
authors.forename: Stephanie T
authors.initials: ST
authors.lastname: Page
authors.forename: John K
authors.initials: JK
authors.lastname: Amory
authors.forename: Bradley D
authors.initials: BD
authors.lastname: Anawalt
authors.forename: Michael S
authors.initials: MS
authors.lastname: Irwig
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Brockenbrough
authors.forename: Alvin M
authors.initials: AM
authors.lastname: Matsumoto
authors.forename: William J
authors.initials: WJ
authors.lastname: Bremner
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D001835:Body Weight / Q000187:drug effects; D003272:Contraceptive Agents, Male / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004333:Drug Administration Routes; D004338:Drug Combinations; D005782:Gels; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors*; D006062:Gonadotropins / Q000097:blood; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008875:Middle Aged; D011506:Proteins; D012738:Sex Hormone-Binding Globulin / Q000032:analysis; D013076:Sperm Count; D013091:Spermatogenesis / Q000187:drug effects; D013739:Testosterone / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D003272:Contraceptive Agents, Male; D004338:Drug Combinations; D005782:Gels; D006062:Gonadotropins; D007328:Insulin; C084797:Leydig insulin-like protein; D008055:Lipids; D011506:Proteins; D012738:Sex Hormone-Binding Globulin; D007987:Gonadotropin-Releasing Hormone; D013739:Testosterone; D017258:Medroxyprogesterone Acetate