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Male birth control gel is safe and effective, new trial findings show

Article Date - 06/02/2024

Every morning for a year and a half, Logan Whitehead, 24, rubbed a clear gel on his shoulders, waited for it to dry, then went about his day as usual.

“It was basically like a hand sanitizer solution,” said Whitehead, who lives in Torrance, California. “Smelled like hand sanitizer, looked like hand sanitizer.”

The gel wasn’t hand sanitizer, though. It was a hormonal solution meant to block Whitehead’s sperm production. The gel was male birth control.

Until this past winter when his participation concluded, Whitehead was a volunteer in a phase 2 trial for the gel. The product — which contains testosterone and a synthetic hormone called Nestorone that reduces sperm production — is the most advanced among a crop of novel birth control options for men.

If the Food and Drug Administration approves the gel, Whitehead said he would definitely keep using it, especially after watching his partner struggle with available female birth control options.

“The gel was such an easy process,” he said. “It was basically like taking the pill for the day.”

Whitehead said he didn’t notice side effects using the gel beyond some upper back acne and possibly a bit of weight gain, although that could have been linked to a new sedentary job.

Hormonal gel trial shows promise
On Sunday, at the Endocrine Society’s conference in Boston, researchers with the National Institutes of Health’s Contraceptive Development Program presented encouraging phase 2 trial results on the hormonal gel.

The trial involved 222 men, ages 18 to 50, who applied 5 milliliters of the gel (about a teaspoon) to each of their shoulder blades once per day.

The second part of the two-part trial is still underway. Initial findings showed that the contraceptive worked faster than expected, according to Diana Blithe, chief of NIH’s Contraceptive Development Program.

After 12 weeks of applying the gel every day, 86% of trial participants achieved sperm suppression, meaning they had only up to 1 million sperm per milliliter of semen, the amount the researchers deemed effective for contraception. On average, the timing for effective contraception was eight weeks.

In comparison, normal sperm counts without contraception can range from 15 million to 200 million per milliliter.

The faster-than-expected timing to suppress sperm is an encouraging sign, especially since past attempts have taken longer to reach these sperm levels, Blithe said in a news release about the new data.

Prior efforts using testosterone alone have required higher doses of the hormone, which can cause side effects. Because the gel includes both testosterone and Nestorone, it acts more quickly and requires less testosterone, she said.

Nestorone is a type of synthetic hormone called a progestin that’s already used in the vaginal ring contraceptive. Combining Nestorone and testosterone in the new gel is meant to keep men from producing sperm without affecting their sex drive or causing other side effects.

So far, the men in the gel clinical trial have shown low enough blood levels of testosterone to maintain their normal sexual function.

Researchers are now tracking how well the gel works to prevent pregnancy. Because of pregnancy risk, male participants are required to be in committed, monogamous relationships, and need consent from their female partners too. The couple must agree to use the gel as their only birth control and to have sex at least once a month for a year. Throughout the study, men have their sperm counts tested periodically, which is a good predictor of fertility. If the sperm counts remain low, the chances of pregnancy are slim.

After decades of early-stage attempts and failures, there are no federally approved male birth control drugs. Only a handful have even advanced into human trials.

It’s not because the approaches haven’t shown potential, researchers say, but because there hasn’t been enough funding or financial investment to complete expensive advanced human trials.

“We’ve been pushing for hormonal male contraceptives for 50 years, but there isn’t enough money available to really drive something through a very large phase 3 trial,” said Daniel Johnston, chief of the National Institute of Child Health and Human Development’s Contraception Research Branch.

If one male birth control drug gains approval from the FDA, pharmaceutical companies and industry investors would put more resources into other medications or products, Johnston believes.

“We’ve been chasing this for a long time,” Johnston said. “I hope we’re entering new territory.”

Nonhormonal options in development
Also on Sunday, YourChoice Therapeutics said a very small trial in the U.K. — just 16 men — showed that its nonhormonal pill, YCT-529, was safe and free of side effects. The San Francisco company’s nonhormonal pill works by blocking the vitamin A receptor important for male fertility.

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YourChoice is planning a larger trial, according to CEO Akash Bakshi.

“We’re excited to see what happens next,” Bakshi said.

Separately, a Charlottesville, Virginia, medical device company, Contraline, is developing a nonhormonal male birth control method that involves injecting a gel into the vas deferens, the tubes that transport sperm from the testicles.

Injecting the gel, called ADAM, involves a single, 15-minute procedure, said Kevin Eisenfrats, Contraline’s CEO and co-founder. Then, the gel is meant to stay in place for years. Contraline compares the long-acting reversible contraceptive to an intrauterine device (IUD) for women.

Contraline has been testing ADAM in an early clinical trial in Australia. In January, the company reported that among 25 clinical trial participants, the approach resulted in a 99.8% to 100% reduction in the number of motile sperm within 30 days of the procedure, Eisenfrats said.

“It’s honestly very similar to the experience patients have after a vasectomy,” he said. “Some of these patients had light bruising and swelling, which go away on their own.”

Contraline hopes to start testing ADAM in the U.S. in 2025.

Because Contraline is developing ADAM as a medical device and not a drug, it may be able to go through a speedier clinical trial and regulatory process than contraceptive drugs like the hormonal gel, experts suggest.

If it goes according to plan — which can be rare for novel products with no precedent — Eisenfrats said he’s aiming for an FDA approval in 2027.