title: Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial.
abstract: OBJECTIVE
  Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone® gels, would be acceptable to study participants as a primary contraceptive method.
  
  
  METHODS
  As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis.
  
  
  RESULTS
  Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03).
  
  
  CONCLUSIONS
  A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men.
  
  
  CONCLUSIONS
  A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose current choices are limited to condoms and vasectomy.
authors: University of Washington, Department of Medicine and Center for Research in Reproduction and Contraception. Electronic address: mylang@u.washington.edu.
authors: Mara Y
authors: MY
authors: Roth
authors: University of Washington, Department of Family Medicine.
authors: Grace
authors: G
authors: Shih
authors: Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Department of Medicine, Torrance, CA.
authors: Niloufar
authors: N
authors: Ilani
authors: Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Department of Medicine, Torrance, CA.
authors: Christina
authors: C
authors: Wang
authors: University of Washington, Department of Medicine and Center for Research in Reproduction and Contraception.
authors: Stephanie T
authors: ST
authors: Page
authors: University of Washington, Department of Medicine and Center for Research in Reproduction and Contraception.
authors: William J
authors: WJ
authors: Bremner
authors: Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Department of Medicine, Torrance, CA.
authors: Ronald S
authors: RS
authors: Swerdloff
authors: Center for Biomedical Research, Population Council, New York City, NY.
authors: Regine
authors: R
authors: Sitruk-Ware
authors: Contraceptive Discovery and Development Branch, NICHD, Bethesda, MD.
authors: Diana L
authors: DL
authors: Blithe
authors: University of Washington, Department of Medicine and Center for Research in Reproduction and Contraception.
authors: John K
authors: JK
authors: Amory
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003272:Contraceptive Agents, Male / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D009653:Norprogesterones / Q000008:administration & dosage*; D010342:Patient Acceptance of Health Care; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D003272:Contraceptive Agents, Male; D004338:Drug Combinations; D005782:Gels; D009653:Norprogesterones; D013739:Testosterone; C029167:ST 1435
keywords: Acceptability; Contraception; Nestorone; Spermatogenesis; Testosterone