There’s a new study making the rounds about a seemingly effective male birth control. The hormonal injection, designed to slow or block sperm production, had a 96 percent success rate at preventing pregnancy among couples who completed the study.
There was just one problem, according to some media reports: The new method won't be available anytime soon because the men in the study were wimps. They couldn’t handle side effects — moodiness, acne — that women on birth control deal with all the time, and so the study had to be terminated.
These stories are wrong and misleading.
The study was halted, but it wasn't because the men who participated in it were wimpy. It was halted because one of the two independent committees that were monitoring the trial's safety data was concerned about the high number of adverse events the men reported. And, yes, the rate of side effects in this study was higher than what women typically experience using hormonal birth control.
Here's what the study, which appeared in the Journal of Clinical Endocrinology & Metabolism, says:
This decision [to terminate the trial] was based on [the Research Project Review Panel’s] review of study [adverse events] and conclusion that the risks to the study participants outweighed the potential benefits to the study participants and to the increased precision of the study outcome findings from having the full cohort contribute to the final analysis.
The 320 men who participated in the research reported a whopping 1,491 adverse events, and the researchers running the trial determined that 900 of these events were caused by the injectable contraceptive.
Nearly a quarter of participants experienced pain at the injection site, nearly half got acne, more than 20 percent had a mood disorder, 38 percent experienced an increased sexual drive, and 15 percent reported muscle pain. Other, rarer side effects included testicular pain, night sweats, and confusion. One study participant died by suicide, though the researchers determined it wasn’t related to the birth control. Twenty men dropped out of the study because of the side effects.
For the safety reviewers, this was simply not an acceptable rate of side effects for otherwise healthy men who were taking the injection not for some disease but for the purpose of preventing pregnancy.
"These side effect rate is pretty high with this new study of men when compared with contraception studies for women," OB-GYN and blogger Jen Gunter wrote. "For example and perspective, a study comparing the birth control patch with the pill found a serious adverse event rate of 2%. The pill reduces acne for 70% of women and in studies with the Mirena IUD the rate of acne is 6.8%." Remember that in the study, nearly half of the men got acne.
The desire to vent about the lack of male contraception — and the side effects the women who use it may endure — is of course understandable; women have always carried the burden of birth control. But we shouldn’t blame the men in this study for that inequality.
In fact, 75 percent of the men wanted to continue using the shot, according to a press release from the study. "Despite the higher than expected number of adverse events, many participants expressed their satisfaction with the method and indicated that their partners were relieved that they did not have to bear the burden of contraception themselves."
Keep in mind, too, this was a large-scale, multi-country trial involving 10 study centers. And there was some concern that many of the adverse events came from one of the study centers, which may have skewed the data. That’s why the researchers said in the press release, "Given the efficacy and acceptability of this method, despite side effects, there continues to be a strong rationale for continuing research."
This isn’t the first time the media has misrepresented a promising male birth control. In 2014, some journalists suggested that Vasalgel, a method of birth control that involves injecting a gel into a man's vas deferens, would hit the market by 2017. In that case, the reports were based on unpublished, anecdotal findings from testing on baboons supplied by the company.