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Why there’s still no new birth control for men

Efforts to develop better male birth control have existed since at least the 1970s, when clinical trials for hormonal methods began, but no new options are available to the public yet. (iStock)

Adrian Gallo’s interest in better birth control methods for men began about 10 years ago, when he was an undergraduate student with a female roommate.

“She told me about the many trials and tribulations of being a woman,” including taking birth control pills, Gallo recalled. “I remember thinking, ‘Oh my God, hormonal pills sound awful, like, truly awful,’ ” which made him wonder why contraceptive responsibilities weren’t distributed more equitably and why there weren’t broader choices for men other than condoms or vasectomies.

Fast-forward to 2022. Much has changed in Gallo’s life; he’s 32 and a PhD candidate in soil science at Oregon State University. His options for contraception, however, remain the same.

“It’s a decade later and still nothing,” he said. “I’m a scientist; I know science is slow. But, like, come on.”

The recent flurry of abortion legislation seems to be driving public interest in the potential for new forms of male contraception, said Heather Vahdat, executive director of Male Contraceptive Initiative (MCI), a nonprofit. “I think socially people are like, ‘What can we do at this point?’ ”

But, she and other experts said, increased interest isn’t likely to speed up the process.

Experts say attempts to bring an effective new contraceptive method to market have been hindered by a number of factors, including limited funding, lengthy regulatory procedures, biological challenges and societal issues such as the long-standing belief that the people who can get pregnant should bear the responsibility for preventing pregnancies.

Opinion: We need a male contraceptive pill. But good luck getting guys to take it.

A long road

Efforts to develop male contraceptives have existed since at least the 1970s (not long after the pill for women became widely available), when researchers started clinical trials for hormonal birth control methods for men. But research occurred in “fits and starts,” said John Reynolds-Wright, a clinical research fellow at the University of Edinburgh who studies male contraceptives and reproductive health. Only in more recent times, he said, has there been an “uninterrupted flow of research studies.”

Researchers recognize that demand for male contraceptives exists. An oft-cited survey published in 2005 of more than 9,000 men in nine countries found that overall acceptance of hormonal approaches was about 55 percent, with roughly 28 to 71 percent of survey participants in the individual countries expressing willingness to use such a method.

Upward of 2,000 men have expressed interest in participating in clinical trials for a new non-hormonal male contraceptive called ADAM, which is designed to block sperm from entering ejaculate, said Kevin Eisenfrats, co-founder and chief executive of Contraline, the Charlottesville-based company behind the implant.

“We’re in quite an exciting point in time, I think, in terms of where things are headed with novel male contraceptives,” Reynolds-Wright said. But he and other experts cautioned that despite the public interest in male contraceptives, a new product probably won’t be available soon.

How far are we from more options for male birth control?

A ‘woman’s issue’

Historically, contraception has been framed as a “woman’s issue,” said Claudia Roesch, a research fellow at the German Historical Institute Washington who studies gender, sexuality and the history of family. Early advocates of the pill presented it as a welcome alternative to existing contraceptive methods, such as condoms or withdrawal, in which effectiveness depended largely on cooperation from partners. “It was understood as a feminist issue of women gaining control over their own bodies,” Roesch said.

But this focus on people who can get pregnant has contributed to the pervasive idea they are “naturally responsible” for contraception, said Krystale Littlejohn, an assistant professor at the University of Oregon and author of “Just Get on the Pill: The Uneven Burden of Reproductive Politics.”

“We socialize people who can get pregnant to believe that it is their job to prevent pregnancy,” Littlejohn said. “We stigmatize them when they don’t prevent it, we shame them when they don’t prevent it, and we hold partners much less accountable for helping to prevent it.”

Additionally, some experts say the success of the pill may be partly responsible for the lag in development of male contraceptive options. “It’s just the female contraceptive pill took hold, and the impact it had on women’s lives was so profound that it became the method,” Vahdat said. “I think in some ways, maybe that’s hindered breakthroughs.”

Funding for contraceptives research and development in general has been limited, Vahdat said, adding that much of the work has been supported by federal funding, such as grants from the National Institutes of Health, and philanthropies. What’s more, many “resources were focused on giving more options to women, which is right,” she said. “That’s absolutely the way it should be.”

But, she said, the contraceptive movement can be viewed as phases, and it’s time to enter “phase two, where we continue to explore better methods for women but also bring more methods for men forward.”

The male contraceptive landscape

Although the existing contraceptive options for men — condoms and vasectomies — are effective, they have drawbacks. Condoms, which are not always used properly, have a typical-use failure rate of about 13 percent, according to the Centers for Disease Control and Prevention. On the other hand, while vasectomies have a high success rate, reversing the surgical procedure can be difficult, expensive and not always possible.

“We’re reconnecting a tube the size of about two to three hair follicles in diameter” using minuscule sutures, said Amin Herati, director of men’s infertility and men’s health at Johns Hopkins.

There are, however, several reversible male contraceptives — hormonal and non-hormonal — being researched and developed. A hormonal gel called NES/T, for instance, which is applied to a man’s shoulders and upper arms once a day, is in the late stages of a Phase 2 clinical trial, said Christina Wang, one of the trial’s lead investigators and a contraceptives researcher at the Lundquist Institute at Harbor-UCLA Medical Center. The trial is in part supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which is part of the NIH and has long funded research and development of male contraception.

In March, researchers at the University of Minnesota announced that they created a non-hormonal contraceptive pill that was 99 percent effective in preventing pregnancy when tested in male mice and that they’re planning to start human trials this year. Meanwhile, Eisenfrats said Contraline is poised to begin its first-in-human trials of ADAM in Australia.

At the moment, Wang said the NES/T gel appears to be furthest along in development, although a Phase 3 trial could take at least five years to complete.

The challenges

Part of the difficulty in developing a new male contraceptive is rooted in biology, Wang said.

“In men, you have to prevent the sperm coming out every day, and every day there are millions,” whereas women usually release one egg a month, she said. A healthy adult man can produce 15 million to more than 200 million sperm per milliliter of semen, according to the Mayo Clinic. Past research suggests sperm counts may need to be reduced to less than 1 million per milliliter to provide a good level of contraceptive protection, said Reynolds-Wright, who is also involved in the NES/T trial at the University of Edinburgh.

Additionally, the development of promising contraceptives can be hindered by a complex regulatory process. Since the development of birth control for women, which included the controversial Puerto Rico pill trials, requirements for bringing a contraceptive to market have become much stricter, Roesch said. “Back then, there were hardly any restrictions or any guidelines about clinical trials.”

Guinea pigs or pioneers? How Puerto Rican women were used to test the birth control pill.

Potential side effects of novel male contraceptives have been a particular concern for regulators, Vahdat said. One promising trial of a hormone injection was stopped early after participants reported side effects, such as acne, injection site pain and mood disorders. The move drew public outcry at the time as many pointed out that widely used birth control options for women can have similar, if not more severe, side effects. The pill, for example, has been associated with an increased risk of blood clots.

“Men get a bad rap for those clinical trials, but it’s not like the men raised their hands and said, ‘Oh my gosh, stop, ew, I have a headache,’ ” Vahdat said. The trials are governed by independent safety-monitoring committees and “that’s who stops the clinical study.”

The difference, Vahdat said, lies in a risk calculus. In the eyes of regulators, she said, men typically aren’t at risk for the serious and potentially deadly effects of pregnancy or birth, which may outweigh the possible side effects of birth control. But Vahdat says that while a cisgender man can’t become pregnant, “that doesn’t mean that he wouldn’t be willing to tolerate a headache or acne” or other possible side effects.

Male birth control pill trials show it causes a side effect that women have faced for decades

Looking to the future

Littlejohn emphasized the importance of addressing social influences such as this one that contribute to the dearth of male-oriented options. “Like many things in our society, there is a focus and emphasis on … making sure that the experience is tolerable for [men],” she said, “and women are just not given the same grace or consideration.”

Changing the “heavily gendered dynamic,” she said, is critical to the successful uptake of new male contraceptives. “If we want our technology to be as effective as possible,” she said, “then we need to keep working harder and harder and harder to change our social narratives so that our social narratives better align with the technologies once they come to market.”

Reynolds-Wright, on the other hand, says social change may follow once an effective male contraceptive becomes available. “Maybe I’m overstating how exciting it is, but I always think of it like the iPhone. We couldn’t have imagined how the iPhone would impact on our lives until it was invented. And actually, this is something that’s got the potential to completely, radically change how we talk about family planning, about relationships, about sex.”