PMID- 31754066
OWN - NLM
STAT- MEDLINE
DCOM- 20200930
LR  - 20210409
IS  - 2515-2009 (Electronic)
IS  - 2515-1991 (Print)
IS  - 2515-1991 (Linking)
VI  - 46
IP  - 2
DP  - 2020 Apr
TI  - Assessing safety in hormonal male contraception: a critical appraisal of adverse 
      events reported in a male contraceptive trial.
PG  - 139-146
LID - 10.1136/bmjsrh-2018-200206 [doi]
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Abbe, Carmen
AU  - Abbe C
AUID- ORCID: 0000-0001-9050-2175
AD  - Department of Medicine, University of Washington, Seattle, Washington, USA 
      carmen.abbe@gmail.com.
AD  - Scripps College, Claremont, California, United States.
FAU - Roxby, Alison C
AU  - Roxby AC
AD  - Department of Medicine, University of Washington, Seattle, Washington, USA.
AD  - Department of Global Health, University of Washington, Seattle, United States.
LA  - eng
GR  - HHSN275201300025I/HD/NICHD NIH HHS/United States
GR  - K23 HD071788/HD/NICHD NIH HHS/United States
GR  - U54 HD012629/HD/NICHD NIH HHS/United States
GR  - P30 AI027757/AI/NIAID NIH HHS/United States
GR  - U54 HD042454/HD/NICHD NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191121
PL  - England
TA  - BMJ Sex Reprod Health
JT  - BMJ sexual & reproductive health
JID - 101715577
RN  - 0 (Contraceptive Agents, Male)
RN  - 0 (Progestins)
RN  - 5W7SIA7YZW (Levonorgestrel)
SB  - IM
MH  - Acne Vulgaris/epidemiology/etiology
MH  - Adult
MH  - Contraceptive Agents, Male/standards/therapeutic use
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/*etiology
MH  - Headache/epidemiology/etiology
MH  - Hormonal Contraception/methods/*standards
MH  - Humans
MH  - Levonorgestrel/adverse effects/therapeutic use
MH  - Libido/drug effects
MH  - Male
MH  - Mood Disorders/epidemiology/etiology
MH  - Patient Safety/*standards/statistics & numerical data
MH  - Pelvic Pain/epidemiology/etiology
MH  - Progestins/adverse effects/therapeutic use
MH  - Weight Gain/drug effects
PMC - PMC8029306
MID - NIHMS1687265
OTO - NOTNLM
OT  - hormonal contraception
OT  - male contraception
COIS- Competing interests: None declared.
EDAT- 2019/11/23 06:00
MHDA- 2020/10/02 06:00
PMCR- 2021/04/08
CRDT- 2019/11/23 06:00
PHST- 2018/08/18 00:00 [received]
PHST- 2019/10/29 00:00 [revised]
PHST- 2019/10/30 00:00 [accepted]
PHST- 2019/11/23 06:00 [pubmed]
PHST- 2020/10/02 06:00 [medline]
PHST- 2019/11/23 06:00 [entrez]
PHST- 2021/04/08 00:00 [pmc-release]
AID - bmjsrh-2018-200206 [pii]
AID - 10.1136/bmjsrh-2018-200206 [doi]
PST - ppublish
SO  - BMJ Sex Reprod Health. 2020 Apr;46(2):139-146. doi: 10.1136/bmjsrh-2018-200206. 
      Epub 2019 Nov 21.