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Assessing safety in hormonal male contraception: a critical appraisal of adverse events reported in a male contraceptive trial
  1. Carmen Abbe1,2,
  2. Alison C Roxby1,3
  1. 1Department of Medicine, University of Washington, Seattle, Washington, USA
  2. 2Scripps College, Claremont, California, United States
  3. 3Department of Global Health, University of Washington, Seattle, United States
  1. Correspondence to Carmen Abbe, Department of Medicine, University of Washington, Seattle, WA 98195, USA; carmen.abbe{at}gmail.com

Abstract

Introduction There is unmet need for male contraceptive options, but a recent injectable combination male contraceptive trial was terminated early due to adverse events (AEs).

Methods We examined the frequency of reported AEs by male research participants compared with AEs reported in prescribing information of approved female hormonal contraceptive methods. Published data from trials of the top five most-used female hormonal contraceptives, supplemented by contemporary contraceptive research, were compared with the frequency of AEs reported in a male injectable hormonal contraceptive trial.

Results We observed similar frequencies of AEs reported by users of male contraceptives compared with those reported by female users. Among quantitatively comparable AEs, compared with men, women reported experiencing higher frequencies of headaches, pelvic pain, and weight gain and similar frequencies of decreased libido. Compared with women, men reported experiencing higher frequencies of acne and mood changes. Men discontinued participation due to AEs at a lower frequency than women.

Conclusions Female hormonal methods generally have similar frequencies of AEs to those reported in a recent male hormonal contraceptive trial, and male users had lower rates of discontinuation due to AEs. There were fewer serious AEs of the male contraceptive than reported in contemporary female trials which resulted in FDA licensure. This suggests there may be implicit bias in the scientific community regarding the level of acceptable risk for users of male contraceptive methods.

  • male contraception
  • hormonal contraception
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Footnotes

  • Contributors CA: data curation, initial analysis, methodology, writing - original draft. ACR: analysis - review and editing, writing - review and editing.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article.

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