Researchers are looking into a new form of birth control, but what’s surprising is who it’s intended for: men.
The University of Utah Health has begun Phase 2 clinical trials for a promising new contraceptive gel for men, paving the way for a shift in the gender dynamics of family planning.
“There’s no better time for men to take more of a shared responsibility for family planning and pregnancy planning,” said David Turok, division chief of family planning at U. Health, who supervises the tests. “We want people to plan their families the way they want and have the sexual experiences they want without risking pregnancy. This has the potential to be a huge step in that direction.
Turok’s team will follow the results of the controlled application of the gel to 12 monogamous Utah couples selected to meet the strict criteria of being healthy, sexually active, fertile, in a relationship for at least one year and “at risk of pregnancy”. The Utah group is part of a larger study cohort of 400 subjects selected from different geographic locations in the United States, Europe and South America.
The brand name of the drug is Nestorone, which is made from a combination of progestogen hormones and testosterone. The progestogen hormone suppresses sperm count in a way that is believed to be reversible. However, progestin also suppresses vital testosterone, which must be supplemented in the gel to counter side effects. Male participants will apply the gel daily to their arms and shoulders for up to 20 weeks, which is about the time it takes for the product to drop a man’s sperm count below the point of fertility.
Researchers will measure participants’ sperm counts 31 times during the two-year study, one of many factors that will determine the drug’s progress to final Phase 3 trials and final approval for commercial use – a result with the potential to change the way people plan their families.
Efficiency is one thing, compliance is another
While drug efficacy is one thing, routine compliance is another. In a world where men have shown haphazard attitudes toward prophylaxis, including attitudinal barriers to condom use, there is reason to wonder whether thorough daily applications might be in high demand. For this reason, the researchers are keen to measure men’s compliance as well as each couple’s overall acceptance of this new method of contraception.
The conundrum of conformity evokes a broader social dynamic and serves as a reminder that science itself is only half the battle.
“Compliance is the huge bugaboo in this whole area. There are many people who can say they are okay with a certain method, but ultimately they are ambivalent. They’re worried about their health or they’re just not fully engaged, and when that’s the case, compliance won’t be great,” said Lisa Diamond, professor of sexuality and psychology at the University of ‘Utah.
Diamond, author and editor of two books on human sexuality, says cultural attitudes, more than reproductive science, may be the steepest slope to climb, and that for now, social mindsets often compromise safe planning beyond the ambivalence of prescriptions.
Diamond points to contemporary research on sexuality in adolescent populations, which she says provides a window into understanding the barriers to effective family planning in society at large. The data indicates that adolescents avoid contraception because it leads to associative guilt, a phenomenon that Diamond says also extends to adults – and this is problematic because abstaining from prophylaxis, contrary to assumptions, does not mean not abstaining from sex.
“If you have birth control or are using birth control, you basically admit to yourself, ‘Oh, my God, I’m sexually active.’ But we see from research that a lot of teenagers are hesitant to buy condoms or take birth control because they don’t want to admit it,” said Diamond, who explained that people find psychological solutions to justify risky sexual behavior anyway.
“Instead, you see an attitude that if this happens, and you didn’t plan for it, then you can say to yourself… ‘I’m not a sexually active person. I did not expect this to happen at all. It’s a total accident, right? »
Diamond believes this “soft denial” and other rationalizations are pervading society at large, posing a challenge to the ultimate goal of Turok’s male contraception study by highlighting the uncertainties of the “human variable.” .
“I think the same is true with conservative cultures, where individuals are ambivalent about even engaging in risky sexual behaviors. It’s a real obstacle to planning because it means you have to admit to yourself, “Yeah, that’s something I expect to do.” So if individuals are not fully able to be honest with themselves about this, they will not show consistent use of contraception. It only serves your ego at the expense of your health,” Diamond said.
“You can develop the most scientifically perfect method possible, but if people don’t use it consistently and correctly, it doesn’t matter. Compliance is everything.
As for the male contraceptive study itself, Turok, who is overseeing phase 2 trials at the U., understands the challenges of compliance and acknowledges that his two-year study invites some unpredictability.
“There are some things we can control and some things we can’t. We understand that people are people. It’s a pretty big commitment. All studies have spin-offs and it is beyond our control,” he said.
With this understanding, Turok designed the study in a way that he hopes to buffer these uncertainties, and believes he can capture the efficacy and safety information that the study was formulated to provide.
Patriarchy or biology?
Conformity and societal attitudes notwithstanding, the outcome of the trial has the potential to usher in profound change in gender relations and spark a discussion about reproductive responsibility that has been swirling for decades.
It’s been 60 years since ‘the pill’ was first made available to women, followed years later by other forms of contraception. Meanwhile, progress in male contraception has been minimal.
“These debates about who is responsible for contraception have been going on since the 1960s. There are always questions about the extent to which a male-focused form of contraception other than the condom was or was not a research priority. People have always asked why it is women who have to take the pill or have an IUD inserted? Why can’t men be more involved with something more reliable than a condom? said Diamond, who describes the gender dynamics of contraception as more multifaceted than meets the eye.
“This raises questions not only about who is responsible for contraception, but who benefits from effective contraception and who is most at risk when contraception fails. There are people who also think a male contraceptive gel is great, but they’ll still say, “Hey, I’m the one who should carry a baby.” I’m not going to trust him. I want to know that I am absolutely protected. I want to know for sure and I wouldn’t trust a man” to consistently comply with the usual birth control regiments like birth control gel, Diamond said.
The contraceptive gel therefore lends itself to couples in long-term relationships, who have established trust and have the ability to verify mutual adherence. Still, if Turok’s clinical trials are successful and the drug moves on to Phase 3 trials and eventual FDA approval, it still leaves the menu of male forms of slim birth control.
Even as disparity continues to fuel suspicions about the gender politics of research and development, the field of sexual biology seems to provide men with an alibi.
“Part of it is the simple logistics of human reproduction. There are two parts to the equation, and basically you’re always trying to figure out how to control one side of that equation, the sperm side or the egg side,” said said Diamond.
Diamond explained that common barrier methods like condoms or cervical caps focus on the end of the sperm equation by preventing sperm from connecting to the egg. But these barrier methods aren’t suitable for all couples and pose compliance issues across demographics, making hormone control methods like the pill attractive alternatives. However, the mechanisms of sperm production were found to be less responsive to hormonal intervention, Diamond said, which partly explains why women have been the focus of these contraceptive techniques.
“We know exactly how to control ovulation. We know how to make this egg unavailable. With hormonal things, it’s just easier to control the egg side,” in part because it’s a process that happens in a shorter amount of time, unlike sperm, which is reproducible in perpetuity, Diamond said.
“The difficulty is to find a method that is both effective and reversible. And that’s something that’s just been a lot easier to do on the egg side of the equation than on the sperm side of the equation.
The Nestorone contraceptive gel, if approved, would begin to change the gender dynamics of reproductive responsibility while adding another resource for family planning. In either case, for Turok, this is not the end of the search.
“It will be an appropriate option for some couples, but there is no birth control method that works for everyone,” he said. “We want to see more options and hope to participate in future studies looking at other options as well.”
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