A new male birth control method, which utilizes a hormonal injection, was designed to slow or block sperm production. However, according to various media reports, this new birth control method won’t be available anytime soon because men are weaklings, unable to handle the side effects, such as moodiness and acne, which women on birth control tolerate. As a result of these side effects the study was terminated.
In between all of the political news that seems to be monopolizing all of our social networking feeds, you probably saw a few articles that said that a male birth control clinical trial was terminated because “men can’t handle side effects women face daily.” Other reputable websites, like the Atlantic, ran headlines pushing the same trope, stating that “a clinical trial of contraceptives for men was halted because of side effects—side effects that women have dealt with for decades.”
But it didn’t stop there. My Twitter and Facebook feeds were flooded with memes that pushed the male birth control clinical trial proves men are wimps compared to women. To be clear, I think that male birth control is a great idea, and sociologically, it forces men to share in the burden of contraceptives. Cynically, I’ll bet that right wingers will be less controlling of male birth control than they are with women’s reproductive rights. But hey, I’m nothing if I’m not a cynic.
The problem with the memes and tropes is that they’re completely wrong. The study was halted because one of the two independent committees that monitor this trial’s safety data (something that happens with all drugs undergoing clinical trials in the USA) was concerned about the high number of adverse events the men experienced. Furthermore, the incidence of adverse events was higher than what is experienced by women using hormonal birth control.
Lucky for us, the data from this study was published in a peer reviewed journal, so we can take a look at what actually happened.
Male birth control study – the facts
The study, published in the Journal of Clinical Endocrinology & Metabolism, reported the Phase II clinical trials (see Note 1) for the intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, which suppresses sperm production. According to the article,
[infobox icon=”quote-left”]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.[/infobox]
There were 320 men included in this Phase II trial – that group reported an almost inconceivable 1,491 adverse events, 900 of which were determined to be caused by the contraceptive, according to the researchers. Think about that – an average of 3 adverse events per participant.
About one-quarter of the participants experienced pain at the injection site, which could be because the intramuscular injection serves as a “depot” for the drugs to be released over time. This isn’t a serious issue, though the number seems high.
About one-half of the participants got acne. This is the one point that caused a lot of the tropes about this male birth control injection – what’s the big deal with acne? Studies on the female contraceptive pill shows that they reduce the incidence of acne by around 70%. The IUD-progestogen device, which is an IUD birth control device with a hormonal birth control drug, has shown to have an acne rate of 6.8%. So two important issues – first, the male birth control drug had a higher rate of acne, and second, acne is considered a serious side effect. If you push the trope that men are wimps, it’s unsupported by the data for this drug.
The study found high rates for other serious side effects:
- Mood disorder – 20%
- Increased sexual drive – 38%
- Muscle pain – 15%
The mood disorder included serious psychiatric conditions such as severe depression. These weren’t minor issues such as “being sad” or something.
The safety review panel had to weigh the adverse events strongly, because this drug was for otherwise healthy men to prevent pregnancy. It’s an elective drug that can be replaced by lower risk and equally effective devices such as a condom. If these adverse events had been observed for a drug that treated a disease, the benefit may outweigh the risk. But not here.
The study authors stated that around 75 percent of the men in the study wanted to continue using the drug:
[infobox icon=”quote-left”]Despite the various AEs and clinically intensive study regimen, male participants and their partners found this combination to be highly acceptable at the end of the trial, even after being made aware of the early termination of the study intervention. More than 75% reported being at least satisfied with the method and willing to use this method if available, which supports further development of this approach.[/infobox]
Not to push this too far, but that doesn’t seem to indicate that these men were “wimps.”
I do understand that women have to endure the burden of birth control, including many of the adverse events associated with them. But a drug intended for male contraceptive use must pass the same levels of scrutiny that any drug would undergo, and there appears to be a much higher level of side effects than seen with female contraceptives.
So what next? The study authors mentioned that many of the adverse events came from one of the 10 study centers involved in this Phase II trial. It may result from randomness or some unknown bias associated with that one center. As with many clinical trials, the researchers review the data and determine if there is a way to proceed. They may discover why there is variability in adverse events from center to center.
According to a press release from CONRAD, the group responsible for this trial, “given the efficacy and acceptability of this method, despite side effects, there continues to be a strong rationale for continuing research.” In other words, this male contraceptive drug still has life left in it because it is effective. If the researchers can clear up the issues with side effects and can show that in clinical trials, then we’ve got something.
- Generally, there are three phases of clinical trials that are required before almost any drug can seek and keep approval from the US Food and Drug Administration. There is also a fourth phase, which is the monitoring of a drug in clinical trials after approval. In Phase II, drugs are tested on a few hundred patients to observe safety and efficacy of the drug. About ⅔ of drugs in Phase II trials never make it to Phase III. Please note that the vast majority of drugs fail to gain approval after clinical trials.
- Behre HM, Zitzmann M, Anderson RA, Handelsman DJ, Lestari SW, McLachlan RI, Meriggiola MC, Misro MM, Noe G, Wu FC, Festin MP, Habib NA, Vogelsong KM, Callahan MM, Linton KA, Colvard DS. Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men. J Clin Endocrinol Metab. 2016 Oct 27:jc20162141. [Epub ahead of print] PubMed PMID: 27788052.
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