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Trial finds male birth control gel to be 86% effective

After decades of trying, researchers say they’re close to bringing a birth control drug for men to market.

The drug, a gel applied to the skin, could be a game changer for men who currently have only two options – condoms or a vasectomy – as forms of effective birth control. It also could shake up the national debate now raging over reproductive rights, abortion and birth control.

“The gel allows men another avenue to take control of their sexual health,” said Dr. Wesley Baas, a urologist at UC Health who’s also an assistant professor in the Department of Surgical Urology at UC College of Medicine.   

The gel, which in clinical trials proved to be about 86% effective, likely won’t reach wide distribution for years, according to Baas, but it may still represent a breakthrough in a field where decades of research have yielded few results.  

The most recent male birth control innovation was the no-scalpel vasectomy in 1974. 

And with reproductive rights in contention, having more birth control options available is critical, advocates say.  

“Following Roe’s overturning, people are rightfully concerned over their sexual and reproductive health,” said Maya McKenzie, a spokesperson for Planned Parenthood in Southwest Ohio.  

“Birth control, in particular, is a major concern.” 

How the new male birth control works

The birth control comes in the form of a clear hormonal gel that is rubbed daily on the shoulders. 

Why the shoulders? “The shoulder blades provide a broad surface area of skin where drugs can be easily absorbed,” said Baas.  

But preventing the hormone from being transferred to others, particularly female partners or children, was also a concern for researchers, according to Baas.  

“The shoulder blades are commonly covered by shirts and thus less likely to transfer to others,” he said. 

The gel contains two hormones: Nestorone, which decreases the sperm count to infertile levels and, as well as testosterone, to help stop the Nestorone from affecting the patient’s sex drive and muscle mass. 

After 12 weeks of applying the gel daily, 86% of trial participants had sperm counts low enough to be considered effective contraception. On average, it took participants eight weeks to reach this level of sperm suppression.

 The advantage of the gel is that it’s temporary, while a vasectomy “is designed to be permanent,” said Baas. 

The gel “should be a reversible method of birth control,” he said, though further testing will need to be done to determine the potential long-term impact on health. 

Men seek more birth control options post Roe v. Wade

While women have more options for birth control than men, they’ve also carried the burden of preventing pregnancy because of it, according to McKenzie. 

“The responsibility for birth control and contraception has fallen on the person who can get pregnant,” she said. “As a result, most existing research and development has largely focused on developing hormonal contraceptives for cisgender women or people assigned female at birth.” 

However, the demand for male birth control options in the U.S. is substantial, according to the Male Contraceptive Institute. 

In 2019, a survey conducted by the nonprofit found that 17 million men in the U.S. between the ages of 18 and 45 sought birth control because they did not want to contribute to a pregnancy.  

Of them, more than 75% said they were open to using new male contraceptive methods.

Male interest in vasectomies may also have been influenced by the Supreme Court’s Roe v. Wade ruling in June 2022. The Cleveland Clinic Center for Male Fertility saw a 35% increase in vasectomy inquiries in July and August 2022, compared to the same months in 2021. 

“I think historically men have not taken as much ownership of their sexual health as we have seen in the last five years,” said Baas. 

Wide distribution of gel years away, expert says

The trial’s results arrive at a contentious time for reproductive rights in the country.  

Last week, Republicans in the U.S. Senate blocked the Right to Contraception Act, which would have protected people’s right to use contraceptives and health care providers’ right to distribute them. 

Meanwhile, the male birth control gel is unlikely to reach mass distribution in the near future. It must complete a phase three trial before receiving approval from the Food and Drug Administration, according to Baas.  

“Phase 3 trials often take several years to design, get approval, recruit, and follow patients,” he said.  

Scientists have been trying to develop a male contraceptive for most of the past half century. The gel is the most promising development in that time, but there’s still a long way to go.

“I would estimate we are at least five years from seeing this drug in the US.”   

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