Contraception for men? University of Utah is investigating contraceptive gel

Researchers are working on a new form of birth control, but what’s surprising is who it’s intended for: men.

The University of Utah Health has started Phase 2 clinical trials for a promising new male contraceptive gel, setting the stage for changing the gender dynamics of family planning.

“There is no better time for men to take more shared responsibility for family planning and pregnancy planning,” said David Turok, chief of the family planning division at U. Health, which oversees the studies. “We want people to plan their families the way they want and have the sexual experiences they want without the risk of pregnancy. This has the potential to be a big step in that direction.”

Turok’s team will follow the results of controlled use of the gel on 12 Utah monogamous couples who were screened to meet strict criteria of being healthy, sexually active, fertile, coupled for at least one year and “at risk of pregnancy.” The Utah group is part of a cohort of the larger study’s 400 subjects, selected from various geographic locations in the United States, Europe and South America.

The drug’s brand name is Nestorone, which is made from a combination of progestin and testosterone hormones. The progestin hormone suppresses sperm count in a way that is thought to be reversible. However, progestin also suppresses the vital testosterone, which must be supplemented in the gel to counteract side effects. Male participants apply the gel to their arms and shoulders daily for up to 20 weeks, approximately the time it takes for the product to reduce a man’s sperm count below the fertile point.

Researchers will measure participants’ sperm counts on 31 separate occasions over the course of the two-year study, one of a variety of factors that will determine the drug’s progress through final Phase 3 studies and its eventual approval for commercial use — one Result with the potential to change the way people plan families.

Effectiveness is one thing, compliance another

While drug effectiveness is one thing, routine compliance is another. In a world where men have shown unsuccessful attitudes towards prophylaxis, including attitudinal barriers to condom use, there is reason to wonder whether thorough, everyday use might be a big question. For this reason, the researchers are striving to measure the men’s compliance along with each couple’s overall acceptance of this new contraceptive method.

The conundrum of compliance addresses larger social dynamics and is a reminder that science itself is only half the battle.

“Compliance is the big bugbear in this whole space. There are many people who say they are on board with a certain method, but when it comes down to it, they have an ambivalence. They’re concerned about their health or they’re just not fully committed, and if that’s the case, compliance won’t be good,” said Lisa Diamond, professor of sexuality and psychology at the University of Utah.

Diamond, author and editor of two books on human sexuality, says that cultural attitudes, more than reproductive science, may be the steeper hill to climb, and currently social attitudes often undermine safe planning in ways that are beyond goes beyond the prescribed ambivalence.

Diamond points to contemporary research on adolescent sexuality, which she believes provides a window into understanding barriers to effective family planning in society at large. The data suggest that adolescents abstain from birth control because it is associated with associative guilt, a phenomenon Diamond says extends to adults as well — and this is problematic because, contrary to belief, abstaining from prophylaxis does not mean abstaining from sex .

“If you have birth control available or you use birth control, you’re basically admitting to yourself, ‘Oh my God, I’m sexually active.’ But what we see from research is that many teens are reluctant to buy condoms or use birth control because they don’t want to admit it to themselves,” said Diamond, who explained that people find psychological workarounds to justify unsafe sex behaviors regardless.

“Instead, you see an attitude that if it just happens and you didn’t plan it, you can say to yourself… ‘I’m not a sexually active person. I hadn’t expected that at all. It’s a total accident, isn’t it?’”

Diamond believes this “gentle denial” and other rationalizations are permeating wider society and complicating the ultimate goal of Turok’s male contraception study by highlighting the uncertainties of the “human variable.”

“I think the same is true in conservative cultures, where individuals are ambivalent about the fact that they even engage in sexual risk behavior. That’s a real hindrance to planning because it means you have to admit to yourself, “Yes, that’s something I expect.” Thus, unless individuals are able to be honest with themselves about this, they will not demonstrate consistent contraceptive use. It’s just serving your ego at the expense of your health,” Diamond said.

“You can develop a method that is as scientifically perfect as 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 oversees the Phase 2 studies at the U., understands the challenges of compliance and acknowledges that his two-year study introduces some unpredictability.

“There are certain things we can control and certain things we can’t. We understand that people are people. It’s quite a commitment. All studies have some impact and that is beyond our control,” he said.

With this understanding, Turok designed the study in a way that he hopes to cushion such uncertainties and believes he can capture the efficacy and safety information for which the study was formulated.

Patriarchy or Biology?

Regardless of compliance and social attitudes, the outcome of the process has the potential to usher in a profound shift in gender relations and brings to the surface a debate about reproductive responsibility that has been simmering for decades.

It has been 60 years since ‘the pill‘ was first made available to women, followed by other forms of contraception in later years. Meanwhile, advances in male contraception are minimal.

“These debates about who is responsible for contraception have been going on since the 1960s. The question arises again and again to what extent, in addition to the condom, a male-oriented form of contraception was a research focus or not. People have always asked why it is women who take the pill or need to be put on an IUD? Why can’t men get their hands on something more reliable than a condom?” said Diamond, who describes the gender dynamics of contraception as more multifaceted than meets the eye.

“The question is not just who is responsible for contraception, but who benefits from effective contraception and who is most at risk when contraception fails. There are some people who also think male birth control gel is great, but they’d still be like, “Hey, I’m the one who would have to deliver a baby. I will not trust him. I want to know that I am absolutely protected. I want to know for sure and I wouldn’t trust a man,'” Diamond said.

The contraceptive gel is therefore suitable for couples in long-term relationships who have built trust and are able to check each other’s compliance. If Turok’s clinical trials are successful and the drug moves into Phase 3 trials and eventually FDA approval, the male birth control menu will still remain thin.

Even if disparities repeatedly give rise to mistrust of the gender politics of research and development, the field of sexual biology seems to provide men with an alibi.

“Some of it is just 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,” Diamond said.

Diamond explained that common barrier methods like condoms or cervical caps focus on the sperm end of the equation by preventing the sperm from bonding to the egg. But these barrier methods are not comfortable for all couples and create compliance issues across all demographics, making hormonal control methods like the pill attractive alternatives. However, the machinery of sperm production has proven less malleable to hormonal interventions, Diamond said, which is partly why women have been the focus of these birth control 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 occurs within a shorter window of time, as opposed to sperm, which are capable of reproduction over time, Diamond said.

“The difficulty is finding something that is both effective and reversible. And that was a lot easier to do on the egg side of the equation than it was 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 any case, this is not the end of the research for Turok.

“There are some couples for whom this will be a suitable option, but there is no birth control method that is right for everyone,” he said. “We’d like to see more options and hope to participate in future studies that look at other options as well.”

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