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    Posted on Nov 3, 2016

    Here's What Everyone Got Wrong About That Male Birth Control Study

    Sorry, folks. It wasn't canceled because the guys were being wimps.

    A new study found that hormonal birth control shots for men could be highly effective at preventing pregnancy.

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    The study aimed to find out if injections of testosterone and progestogen would suppress sperm count enough to prevent pregnancy — and it did!

    Starting in 2008, researchers enrolled men at 10 study sites around the world to test the safety and efficacy of a male birth control shot. Overall, the failure rate was just 7.5%.

    That's pretty awesome news. But all anyone can talk about is how the study ended in 2011 after significant side effects were reported.

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    The popular narrative (including a post published by BuzzFeed) was that the men were wimps who couldn't handle the side effects, or that the researchers were out of line for halting a study due to the same adverse events that women experience on hormonal birth control. Boo men! Boo science!

    But none of that is true.

    Here's why they actually stopped the study:

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    BuzzFeed Health talked to one of the study co-authors, Doug Colvard, PhD, deputy director of programs for Conrad (a co-sponsor of the study), for the real story.

    At the beginning of the study, an independent Data Safety and Monitoring Committee (DSMC) was created by the study sponsors. A DSMC is typical in most clinical studies to ensure an independent review of safety. This committee received preliminary data throughout the study to make sure it was all running smoothly. In addition, the researchers also reported every year to a separate review panel within the World Health Organization (WHO).

    During one of these regular reviews, the panel noted that certain side effects, especially mood swings and increased libido, were more common than expected. So they decided that the risk of men continuing in the study outweighed the benefits of continuing the study to the end to obtain more complete effectiveness and safety data. They recommended that new participants should not be enrolled and that injections should stop, with all men transitioned to the recovery phase of the trial.

    The most frequently reported side effects included acne, increased libido, injection site pain, muscle pain, and mood disorders.

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    Out of nearly 1,500 adverse events reported, about 39% were determined not to be related to the medication.

    That means the majority of side effects were thought to be possibly, probably, or definitely related to the medication, including one case of depression, one case of intentional overdose, and one case of irregular heartbeat after stopping the injections.

    A few limitations worth noting here: The men weren't specifically questioned about depression, anxiety, or mood swings prior to the study. And, for obvious ethical reasons, there was no placebo group in this study. Interestingly, most of the adverse events were reported at one study site in Indonesia, though the study authors do not speculate as to why that may be the case.

    Sure, some men dropped out of the study due to side effects. But that's normal for any study.

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    There were 20 men who dropped out over the course of the study due to medication-related side effects, which isn't unusual in clinical trials.

    "The men participating voted with their feet if they didn't find the side effects acceptable. They withdrew from the study," said Colvard. "But by far the vast majority of the men continued in the study even though they were experiencing mild or moderate adverse events."

    In fact, more than 75% of participants reported being satisfied with the method and willing to use it if it was actually available.

    So to say this study was called off because men couldn't handle the same side effects women experience on hormonal birth control just isn't accurate.

    Monik Markus / Creative Commons / Via Flickr: 42954113@N00

    For starters, you can't compare personal experience on a medication to a phase II trial of a drug that isn't yet on the market.

    "This is an early study of a new drug, and there are so many things we don't know about it," Dr. Jennifer Gunter, OB-GYN, told BuzzFeed Health. "You need to compare that with an equivalent study of birth control to have a comparison. But I don't believe that there's some kind of medical conspiracy to protect men from birth control side effects."

    Not to mention, birth control is actually known to treat acne in women, not cause it, said Gunter. Muscle pain and injection site pain also aren't common side effects. And these researchers found a delay in fertility for some of the men, with eight participants taking longer than a year to return to full fertility. These are not established side effects of most birth control methods.

    And about those mood changes...it's true that many women experience them while on hormonal birth control, and you should absolutely talk to your doctor if that's the case.

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    There's been a lot of research on the association between hormonal birth control and depression, with very mixed results. BuzzFeed Health spoke with epidemiologist Chelsea Polis, PhD, for more information.

    In a recent study of over 1 million women aged 15–34, the use of combined oral contraceptives was associated with a 10% higher risk of depression and a 20% higher risk of using antidepressants. This risk was higher for other hormonal options, and it varied depending on the method. That said, just 2% of the women in the study were newly diagnosed with depression, and just 13% started using antidepressants during the study, so the actual risk of both was still quite low. And this still doesn't prove causality, since several other factors could be at play.

    Still, if you're experiencing significant side effects — like mood changes — on your birth control method, talk to your doctor about other options that are available to you.

    Sure, it sucks that we're not closer to having a male birth control option, but shaming the men and researchers involved in these studies probably won't help.

    Esurance / Via livememe.com

    "Certainly if you want more men to enroll in these studies, calling the ones who report side effects wimps is not the way to go about it," said Gunter. "That's no way to further the goal of male contraception."

    There are always going to be risks associated with any form of medication, and birth control is no exception. But we also have decades of research evaluating the safety and efficacy of hormonal contraceptives for women. Hopefully, someday, we'll be able to say the same for male birth control, too.

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