This article originally appeared on Broadly in the US.
According to news headlines, birth control for cis men has been “coming soon” for the last several years.
A Reuters story from 2012 assured a birth control for men could “soon be a reality.” In 2014, The Daily Beast insisted a contraceptive gel would be available by 2017. In 2017, CNBC promised, tantalizingly, that doctors were “on the cusp” of bringing consumers the first male contraceptive. Last year, Broadly ran a similar headline, declaring “A Safe, Effective Birth Control Pill for Men May Soon Be on the Way.”
These headlines are frustrating not only for those of us eager for men to share the burden of birth control, but for doctors and researchers who know the truth: A future where male birth control is available to the public is still far away. Getting a birth control for men to market will require overcoming hurdles in the drug development process, winning over the pharmaceutical industry, satisfying FDA safety standards, and reckoning with our culture’s deep-seated gender expectations. In other words: It will require a lot of patience.
“When I see stories that say, ‘Male birth control coming soon,’ I just pull out my hair, because I know how long it’s going to take,” Diana Blithe, a leading researcher who’s been studying male contraceptives since 2005, told Broadly. “Everyone says, ‘Five years, sure!’ I make reporters depressed. That’s not going to happen.”
On the phone earlier this month, Blithe described the steps it would take to get a contraceptive gel—the contraceptive product for men furthest along in clinical trials, and the one she’s currently studying at the National Institutes of Health (NIH)—to market.
After Blithe finishes the gel’s current round of testing, which involves proving that the gel has been effective for the study’s 400 participants, she and her colleagues will need to find another 1,600 men willing to test the product. Recruiting them will take several months, and conducting the study will take several more. When that phase is complete, researchers will need to analyze and publish the results, repeating this process until they complete three phases of clinical trials. Then they’ll present their findings to the United States Food and Drug Administration; FDA officials may ask for additional studies to further prove the gel’s safety, effectiveness, and/or recovery, which could mean heading back to the lab and doing some of these steps all over again.
This lengthy process isn’t exclusive to Blithe’s contraceptive gel: Other male birth control methods, like the pill and the injection, are making their way through this timeline, too, as any first-time drug would have to.
“What I described to you is more than 10 years away,” Blithe said.
Like the female birth control pill, research for a hormonal male contraceptive began in the 1950s. Gregory Pincus—the biologist who would eventually develop the first female oral contraceptive with the help of gynecologist John Rock—first began testing estrogen and progestin on men and women inside Worcester State Hospital, a Massachusetts asylum for the mentally ill, without their knowledge or consent.
When birth control activist and Planned Parenthood founder Margaret Sanger—who helped fund Pincus’s research as part of her advocacy for women’s bodily autonomy—learned that Pincus was testing on men as well as women, she convinced him to focus on women only. It helped that Katherine McCormick, the women’s rights activist Sanger recruited to fund the majority of Pincus’s research, agreed. From Sanger and McCormick’s perspective, men already had condoms; women needed their own way to prevent their husbands from impregnating them at will. Besides, Pincus and Rock were already making progress developing a female pill.
“The only reason that anyone was investigating birth control is because women had a huge incentive to do so,” Jonathan Eig, author of The Birth of the Pill, told Broadly. “Margaret Sanger and Katherine McCormick were willing to personally fund the studies and assume enormous risk because women needed control over their bodies, and that’s what drove the research. There was no such incentive to do research for men.”
Some insist there still isn’t, and say a lack of demand explains why, over half a century later, we still don’t have male birth control. From the moment the FDA approved the first pill for women, it was an unmitigated success, so much so that its popularity halted research into a male counterpart for the next decade, according Eig. As of 2014, more than 9.5 million women in the US reported taking the pill, and about 16 million others use some other form of birth control other than condoms, making up a roughly $20 billion industry. Despite the breathless way the media has covered incremental developments in the search for an effective male birth control outside of condoms and vasectomies, the question remains: Do men even want it?
Charley Lanyon, a 33-year-old journalist living in Los Angeles, “very strongly” does. He wants to be more responsible; he doesn’t want the burden of contraception to fall solely on his partner; he doesn’t want to feel like, in his words, “a shit bag.” More than anything, he wants to take birth control because his partner cannot. Lanyon’s current girlfriend was on oral contraceptives for 10 years, during which she battled depression and mood swings. After getting off the pill, her mental health drastically improved.
“If you look at this, the argument is like, 'Please go back and be depressed again,'” Lanyon said. “That's horrible. It's not like no one's doing their part; there's really just no option. It's like, Does she want to be miserable, or do we take no consistent birth control? That doesn't seem fair.”
Jelani Rice, a 25-year-old photographer living in Brooklyn, also believes the available birth control methods are unfair. Rice recalled a relationship in which his partner assumed she had to get on birth control if they were going to date; it made Jelani feel like he was controlling her decisions about her body. “I almost feel like men just assume that's just what a woman does, and women also assume that that's what [they] have to do,” he said.
The relationship has since ended, but Rice still sees a need in his life for male birth control. He wants to have sex as safely as possible, and hoping that a woman has been taking her pill on time or that she changed her patch on the right day doesn’t feel like enough. “I would love to be able to 100 percent know I'm doing what I can on my end to have protected sex,” he said.
Both Lanyon and Rice say they understand that, like any other medication, birth control will include side effects—and they’re okay with that.
The idea that men aren’t willing to tolerate side effects associated with taking birth control gained traction in 2016, when researchers reported ending a 320-person study on a long-acting injection after 20 men dropped out due to side effects like muscle pain, intense changes in mood, and acne. The report was met with outrage: Women, many pointed out, had been dealing with similar side effects for decades now—why couldn’t men? The side effects, however, had also been much more severe than that, and included a case of depression, an intentional overdose on pain medication, and one subject who experienced “an abnormally fast and irregular heartbeat” after he stopped the treatments.
Nonetheless, the results of the study were largely positive. Seventy-five percent of the men reported that they’d still be willing to use the product despite some of the more minor side effects that occurred—a high rate of satisfaction for any study, according to Blithe.
Blithe says it makes sense that large swaths of men are interested in the product. Men are already using male birth control at high rates: Male condoms and vasectomies both rank among the top five most common forms of birth control women rely on.
“Men say they don’t like using condoms,” Blithe said, referring to a pervasive cultural cliché. “If they had another option, would they use it? I think the answer is yes.”
Research suggests there’s truth to Blithe’s theory: A recent survey from the Male Contraceptive Initiative found that 8.1 million men in the US are “very likely” to use new male contraceptive methods, while 5.6 million are “somewhat likely.” Another study published in the National Center for Biotechnology Information in 2002 found that 75 percent of male partners of women who had recently given birth would consider trying male hormonal contraception. Still, tubal sterilization, a procedure that closes the fallopian tubes, remains four times more popular than vasectomies, even though the latter is far less intrusive and often reversible.
Polls gauging interest in contraceptives for men dropped off for the most part in the early 2000s, to the chagrin of researchers like Stephanie Page, the division head of the Metabolism, Endocrinology and Nutrition department at the University of Washington, who suspects new polling would reflect a growing demand for them.
“There’s been a lot of social change in the last 10 to 15 years,” Page said. “I would say there’s probably even more interest in a male contraceptive than before.”
“Men say they don’t like using condoms. If they had another option, would they use it? I think the answer is yes.”
Still, as far as the pharmaceutical industry is concerned, the market for male birth control is unknown because it remains hypothetical. “Many new drugs we see on the market are either longer-acting forms of something that already exists or treat a disease or disease state, so we already know how many people might take it,” Page continued. “With male birth control, that’s unknown, because there’s nothing like it available.”
The pharmaceutical industry wasn’t always reluctant to fund male contraceptive research. When studies on male birth control resumed in the 70s, led by the NIH, researchers hit on a major breakthrough: With the continued use of testosterone, they could suppress men’s sperm counts to effectively infertile levels. In the 90s and early 2000s, scientists conducted similar studies involving giving men high doses of testosterone, this time with larger and more diverse subject pools—and, crucially, with the backing of pharmaceutical companies. But, while effective, the excess testosterone caused some men to experience an array of undesirable side effects, like the inability to ejaculate and maintain muscle mass, as well as low libido and extreme mood swings.
The past few decades of research have been able to correct for these problems: Hormonal contraceptives currently being tested for male use—gels, injections, and pills—typically use testosterone in conjunction with a second hormone or hormone compound to stop sperm production while regulating the testosterone levels in the rest of the body. Page, who is currently working on multiple forms of hormonal male birth control, suspects the negative side effects of earlier studies scared off Big Pharma, making it seem as though testing male contraceptives was a risky—and perhaps futile—endeavor.
According to Time, Bayer, a top seller of female birth control products, abandoned its research into male birth control around 2007 with no plans to pursue any future studies. And in 2015, a Bayer spokesperson told The Atlantic that a male contraceptive wouldn’t be “as convenient as a woman taking a pill once a day.” Two years later, Bloomberg reported that male contraception wasn’t an “active area of research” for other major pharmaceutical companies, including Pfizer Inc. and Merck & Co., either. In an email to Broadly, a Merck spokesperson confirmed that this hasn’t changed. Representatives for Bayer and Pfizer didn’t respond to requests for comment.
“We have a capitalist system for developing drugs, which means, ultimately, we need [financial] support from somewhere to accelerate the development process,” Page said. “There’s no question that an infusion of resources would do that.”
Some, like Page, believe pharmaceutical companies’ unwillingness to invest stems from the stubborn idea that men would never want to shoulder the burden of birth control, or that women wouldn’t trust them to. (As early as 2000, an Oxford study surveying women across the world on whether or not they’d trust men to take the pill found that they would.)
Others—like the The Male Contraceptive Initiative, a nonprofit organization founded in 2014—say the struggle to find big investors is typical of any new area of research. The organization has attempted to address what it views as a dire funding gap for all contraceptive studies, including birth control for men. “My impression is less that it’s about any sort of organized effort against male contraception, and more of an honest prioritization of addressing women’s needs first,” said Heather Vahdat, the executive director of MCI. “That’s where most of the disparity comes from: lack of resources.”
Since 2017, MCI has dispersed $1.7 million in funds from private donors toward global male contraceptive research, specifically to those studying non-hormonal birth control methods, which include methods that “prevent sperm-egg interaction” and the development of new sperm, as well as those that block sperm from passing through the vas deferens. MCI prioritizes these studies because they’re at the earliest stages of development, and because Vahdat and her colleagues believe non-hormonal methods will be “better received” once they’re available to the public because, since they rely on mechanical means of preventing sperm from fertilizing an egg, they don’t produce the same side effects as hormonal birth control.
“We have a capitalist system for developing drugs, which means, ultimately, we need [financial] support from somewhere to accelerate the development process."
But hormonal birth controls like NES/T, the product Blithe and her colleagues are studying at NIH, are the male contraceptive products furthest along in clinical trials and appear to have the best shot at reaching the market most quickly.
NES/T started out as two contraceptive gels—one containing testosterone, and the other, a progestin compound called Nestorone, for which the product is named—that men applied to two different parts of the body. Blithe found this version of NES/T could reduce men’s sperm count to zero within six months if they used it every day, and that men could recover sperm to normal levels in about 24 weeks if they stopped taking it. After publishing the results from that study in 2015, Blithe and her colleagues combined the two gels into a single product, which they’re currently testing on men with female partners. Blithe says the men are responding positively to the gel, and she’s getting ready to enter the phase of the study that involves female participants abandoning their own birth control to put its effectiveness to the test.
“Everything’s going just as we hope it would at this point,” Blithe said. “Check back with me in two years, and I’ll tell you if it’s continued to go well. And two years from then, I’ll have the full results for you.”
Whether it’s the gel, shot, or pill that hits the male birth control market first, researchers agree that once one of these products is available, others will likely flood the market soon after. It’s getting the first one there that’s so difficult.
Not far behind NES/T—the birth control product for men that is closest to market— is a birth control pill called dimethandrolone undecanoate, or DMAU. Last year, Page, a lead researcher studying the pill, presented her findings on a month-long stage 1 study on DMAU, which she and her colleagues proved effective in a 400mg dose. Her team is currently working on enrolling 100 men in the study’s next phase, which she estimates will be completed by next year. Simultaneously, she and her team are also working on an injectable form of the drug.
“Putting a single option on the market and demonstrating that men are interested and will use it will help advance the conversation and get men more used to the idea of being involved in contraception,” Page said. “The goal here is to create a menu of choices for men.”
Blithe knows it can be, as she put it earlier, “depressing” to consider the long road ahead for male contraceptives. But she’s not depressed, even as she reflects on having worked on a birth control for men for the last 14 years, and looks forward to at least another decade of research before she sees it pay off.
Often, she says, she wishes she had a time machine to catapult her 10 years into the future to see if NES/T or any other form of contraceptive for men has made it to the market, and how it’s been received by the public. Still, most days she’s simply patient: She works on the task in front of her; she knows the process can’t move along much faster than it is right now.
Blithe brightens when asked what will happen after that first product gets to market.
“The second one won’t take 30 years,” she said. “The second one will go faster.”
This article originally appeared on VICE US.