Curtis Vaughn is 30 and at a point in his life where he’s done having kids. It was a realization that allowed the young father to confidently choose to have a vasectomy. In the years leading up to that surgical procedure, he closely followed research on male contraceptive options. “I was wishing I had a real option,” he says.
“The ability to add an additional layer of protection that I controlled would have provided a massive sense of relief among all the stories of broken or degraded condoms, missed pills, freak ineffectual hormonal control, and other unplanned events,” Vaughn tells Inverse.
“As a father, I would certainly love to have the option available for my son, when he gets old enough to begin his own sex life, and would similarly feel better if my daughter’s potential partners had that option as well, when she is ready for such things. I’ve discussed the matter with several friends, and while a couple refused the idea for one reason or another, most agreed that they wish there was an option available.”
For women, there are dozens of birth control options. There are pills, patches, diaphragms, and caps. A birth control sponge is available, too, as is the IUD and a rod the size of a matchstick that’s implanted in the arm.
Meanwhile, male contraception has been limited to the same two options for the last 100 years: condoms and a vasectomy. Neither is ideal. Condoms have a high failure rate and vasectomies are difficult and expensive to reverse. Still, these two options make up 30 percent of all contraceptive use.
What scientists have known since at least the 1970s, and what they still know today, is that there’s a need for better and simply more forms of male birth control. As of now, women unequivocally shoulder the primary responsibility for family planning — yet difficult side effects can keep women from using their options. And the fact of the matter is that this situation can result in a surprise. Nearly half of all American pregnancies are unintended, mirroring a worldwide trend.
This leaves us with a gap to be filled, explains Jill Long, M.D., a medical officer with the Contraceptive Development Program at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
“A new male method would allow men to have a greater ability to participate in family planning — both to have greater agency in deciding when they want to reproduce and to increase contraceptive options when the female partner is not able to use existing methods,” Long tells Inverse.
“This would benefit society in providing men and women greater freedom to decide when or whether to have children and potentially decrease the rate of unplanned pregnancy.”
The male birth control ideal
John Amory, M.D., is a physician and a professor at the University of Washington. Amory also might be the person responsible for developing a reversible form of male contraception.
The ideal form of male contraception, Amory explains to Inverse, meets six criteria: It needs to be safe, reversible, easily administered, easily monitored, cost less than $300 a year, and be at least 99 percent effective.
According to Amory, given the physiology of sperm production, a male contraceptive can work in one of three ways:
- By preventing sperm from reaching the egg by a physical barrier. That’s something like the condom or the jiftip — if the jiftip actually worked.
- By killing or inhibiting the function of sperm or the sperm’s ability to bind to the egg — that’s something like spermicide.
- By preventing sperm production by either hormonal or non-hormonal methods.
That last one is the main focus of male birth control research. The issue is that men make a lot of sperm — about 1,500 sperm a second. To be effective, male contraception would have to turn that production rate down to one percent of its normal output.
In turn, hormonal methods have been the most studied approach to suppress sperm production. But while several hormonal male contraceptive agents have entered clinical trials, an effective oral testosterone product has not yet been developed.
The challenge of a “male pill” is that oral testosterone is cleared too rapidly to be effective as a single daily dose regimen, even in combination with a progestin — an artificial form of progesterone, a hormone that males need to produce testosterone.
Some studies have shown that when testosterone and progesterone are administered together, that combination can suppress brain signals that tell the testes to make sperm, and in 90 percent of men, sperm production stops after three to four months. But 90 percent isn’t enough.
Other challenges have emerged as well. In 2016, scientists reported in the Journal of Clinical Endocrinology & Metabolism that they developed a shot that reduces the amount of sperm in semen and worked with an effectiveness rate of 96 percent. That’s better than condoms, which are thought to be realistically 85 percent effective after you factor in human error. But the problem with the shot is that it led the 320 participants to report a total of 1,491 “adverse events” like depression, muscle pain, and acne. The side effects were serious enough that the scientists decided to stop enrolling men into the trial.
At the moment, there’s work being done to develop new synthetic androgens (hormones that play a role in male traits and reproductive activity) that can bind progesterone receptors, and in turn, potentially work as the foundation of contraceptive drugs. But Long explains that as of now there’s only one potential form of male birth control that’s currently being tested for use as a contraceptive in clinical trials: Nestorone®/Testosterone gel.
Our best shot — for now
“The product that is currently the furthest in clinical development is the Nestorone®/Testosterone gel,” Long explains. “It is the only product that is ongoing in development and currently being tested for use as a contraceptive in clinical trials. Other products that have been evaluated in clinical trials in the past [like testosterone undecanoate and norethisterone acetate] are not in continued development.”
Nestorone®/Testosterone gel is a form of contraception that can be rubbed into a man’s shoulders and back once a day, taking advantage of the transdermal effectiveness of testosterone. The gel formulation was developed by the Population Council and the NICHD. It combines the progestin compound segesterone acetate (brand name Nestorone) in combination with testosterone. Previous work has shown that when it’s absorbed through the skin, the progestin blocks testosterone production in the testes, which reduces sperm production to low or nonexistent levels. Meanwhile, the replacement testosterone maintains the man’s sex drive and minimizes side effects like acne, weight gain, and altered cholesterol levels.
So far research has shown that the gel is well tolerated without serious adverse events. Now the gel is being used by couples at test sites in seven countries as part of a Phase 2 study designed to test the gel’s efficacy, safety, and how willing guys are to actually use it. In 2018, couples began to be enrolled in the study, and the plan is to enroll 420 more couples through 2019.
If all goes well and Nestorone®/Testosterone gel is approved by regulatory authorities, it will be a first for men’s contraception. But it also won’t be available at a pharmacy any time soon.
“At the current pace of development,” Long says, “the soonest a new male contraceptive method would make it to the market is approximately 20 years.”
What happens during the next 20 years?
While couples try out Nestorone®/Testosterone gel, other forms of male birth control will continue to be developed. Non-hormonal methods look to be a promising alternative but still need to be extensively tested and tried out by humans.
For example, Amory and his colleagues are conducting preclinical work on non-hormonal male contraception based off a compound called WIN 18,446. Crucial to their work is the knowledge that males need vitamin A to make sperm. When vitamin A is ingested, it’s converted by enzymes into retinoic acid. They’ve found this compound has the ability to block the conversion process from vitamin A into retinoic acid. When the testes are deprived of retinoic acid, sperm production stops. This approach is being tested in animals, with the hope of moving to human testing soon.
Amory also thinks Vasalgel is “worth looking into.” He explains that it “seems to work well for contraception but doesn’t seem to be 100 percent reversible.”
Vasalgel is the trademarked name for a potential other type of long-acting, non-hormonal male contraceptive. It involves a procedure that was initially developed in India during the 1980s and has been shown to successfully work for rabbits and rhesus monkeys.
Importantly, Vasalgel appears to be reversible. What happens during the procedure is that a polymer gel is injected into the vas deferens — ducts that transport sperm — and accordingly, the gel blocks the passage of the sperm. In the rabbit study, it successfully stopped pregnancy for the duration of the 14-month trial. In the end, the gel was flushed out and sperm flow returned after the reversal. Meanwhile, in the monkey study, Vasalgel stopped pregnancies over the course of the study’s two-year period. The studies showed that sperm are too large to move through the gel barrier, and when they hit it, they are absorbed by the body.
Vasalgel is inching toward human trials, in part boosted by a $200,000 grant from the Male Contraceptive Initiative (MCI), a private non-profit that focuses on the development of non-hormonal methods.
Heather Vahdat, the executive director of MCI, anticipates that either Vasalgel or another product similar in scope, called Echo-VR, will be the first options supported by the MCI to reach the market — some time in “10-plus years.”
Vahdat tells Inverse that apart from those two potentials, there’s a range of products in the very early stages of development that hold a lot of promise. The goal is to create a future where men have just as many options as women — to establish what Vahdat describes as “true contraceptive choice.”
“We are aiming for a contraceptive method mix that benefits everyone, so that partners can consider their future together or individuals can protect themselves,” Vahdat explains.
But one concern is that a lack of cash could keep Vasalgel from ever being a real option. Vasalgel is being developed by the Parsemus Foundation a non-profit that takes on products pharmaceutical companies ignore. It collects donations — but it usually takes pharmaceutical company-levels of cash to actually get a product to market. The National Institutes of Health is the largest domestic funder of male contraceptive research, while MCI is one of the largest funders globally. They’ve donated just over $2 million to various research programs since 2017, which, while impressive, is still a small amount in the world of pharmaceutical product development.
Back in the 1990s, pharmaceutical research and development for male contraception was an active space. But since then, Long explains, it’s been virtually abandoned.
“The thought is that industry pulled away from male contraceptive development due to concerns that the market was already saturated with female methods,” Long says. “Moving into the male market, where the risk profile is uncertain, was too risky.”
The issue of masculinity
The big question underlying all of this effort and all of this research is: Will men actually use these different options? Amory’s instinct is yes. He points out that men already account for 30 percent of all current contraception use, and that’s with “two unpopular methods.”
“If we had a safe, effective male contraceptive, men would use it for sure,” Amory says.
But some research indicates there could be a few hurdles before acceptance and adoption. In a study published in the April edition of Psychology of Men & Masculinities, researchers examined the willingness of college-aged men to use hormonal contraception. The study found that perceived risk of unplanned pregnancy was associated with a willingness to use contraception, while men who associated using hormonal birth control with femininity were less likely to be willing.
First author Laurel Peterson, Ph.D., an assistant professor of psychology at Bryn Mawr College, was inspired to conduct the study in part because there’s so little research on men’s attitudes or awareness of male hormonal contraception.
“I study the sexual health of emerging adults and was intrigued that, when I would bring up male hormonal contraception, people would sometimes say, ‘Men would never, ever take that,’” Peterson tells Inverse. “In contrast, some men in the emerging adult age range told me that they would love to have a male contraceptive option. We needed data on these questions.”
She believes that the results from this sample suggest that a substantial proportion of college men are interested in the idea of male hormonal contraception, but maintains that the barriers to its adoption are complex. Peterson says that we can’t ignore social barriers — the idea that men sometimes see contraception as a challenge to their sense of masculinity.
Those who also have to be included in this conversation, she emphasizes, are the partners of these men and trans and non-gender conforming people who are also interested in preventing pregnancy. After all, the goal of male birth control is a composite of desires. Preventing or choosing pregnancy is the foundation, sure, but it’s also about allowing family planning to be made by the people who could become a family. It takes two to tango, but for now, it’s often on one to make sure that tango doesn’t turn into an infant.
Liam McCartney, also 30, is in a relationship and not at a point in his life where he’s considering a vasectomy. Still, he’s open to other forms of contraception that aren’t condoms. He explains to Inverse that “anything that alters you on a chemical level would give me pause,” so he’s less comfortable with a hormonal method. But McCartney definitely thinks men should have more options, which he anticipates would lead to fewer unintended pregnancies.
“It seems odd to me that, to date, the only options for men are the vasectomy and the condom, whereas there are several more options for women,” McCartney says.
McCartney and Vaughn are the type of men that Vahdat, before she started working at the MCI, was told weren’t really out there — men who were open to rethinking what it means to be a heterosexual man taking care of his reproductive health. That archetype, she explains, has held up contraceptive development in the past.
“There was this sense that men just aren’t interested, but evidence suggests that’s not the case,” Vahdat says. “I really believe in the potential of contraception in general for changing people’s lives. I just really hope people understand the gravity in that.”