An innovative gel may become the first birth control method for men in the US.

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

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

But the gel was not hand sanitizer, but rather a hormonal solution to block Whitehead's sperm production. In essence: a male contraceptive.

Until last winter, Whitehead volunteered in a Phase 2 clinical trial for the gel. The product, which contains testosterone and a synthetic hormone called Nestorone that reduces sperm production, is the most advanced of the new contraceptive methods for men.

If the Food and Drug Administration (FDA) approves it, Whitehead said she would continue using it, especially after seeing her partner struggle with contraceptives available to women.

“The gel was a very easy process,” he said, “it was like taking the daily pill.”

Whitehead said he noticed no side effects beyond acne on his upper back and a couple of extra pounds, although that could be related to his new, more sedentary job.

A promising clinical trial

At the Endocrine Society conference in Boston on Sunday, researchers from the National Institutes of Health's (NIH) Contraceptive Development Program presented encouraging results from a Phase 2 trial for the hormonal gel.

The study involved 222 men between 18 and 50 years old, who applied 5 milliliters of the gel (about a teaspoon) to the shoulder blade, once a day.

The second part of the essay, divided into two, still continues. Initial results indicated that the contraceptive was working faster than expected, according to Diana Blithe, head of the NIH's Contraceptive Development Program.

After 12 weeks of applying the gel daily, 86% of the participants achieved sperm suppression, that is, they had up to 1 million sperm per milliliter of semen, which is the amount that researchers consider effective in preventing pregnancy. On average, the time to effective contraception was eight weeks.

Normal sperm counts without the use of contraceptives can range from 15 to 200 million per milliliter.

That sperm suppression is faster than expected is an encouraging sign, especially since previous clinical trials took longer to reach these levels, Blithe explained in a news release about the new data.

Designed not to reduce sexual desire

Previous testosterone-only efforts have required higher doses of the hormone, which can lead to side effects. Since the gel contains testosterone and Nestorone, it acts faster and requires less testosterone.

Nestorone is a type of synthetic hormone, known as progestin, that is already used in ring-shaped vaginal contraceptives. The combination in the new gel is intended to prevent men from producing sperm, without impacting their libido or causing other side effects.

So far, clinical trial participants have shown blood testosterone levels low enough to maintain normal sexual function.

Researchers are now studying the gel's effectiveness in preventing pregnancy. Given the risk, participants must have a monogamous and committed relationship, and also need the consent of their female partners who must commit to using the gel as the only contraceptive method, and having sexual relations at least once a month for a year.

Throughout the study, the men's sperm count, which is a good indicator of fertility, is analyzed periodically. If this count is low, the chances of pregnancy are slim.

The first male contraceptive

After decades of attempts and failures, there are no federally approved male contraceptives and few have been tested in humans.

Researchers say the reason is not a lack of potential, but rather that there has not been enough funding or investment to complete the expensive advanced human trials.

“We have been promoting male hormonal contraceptives for 50 years, but there is not enough funding to conduct a large-scale Phase 3 trial,” said Daniel Johnston, chief of the Contraception Research Section at the National Institute of Child and Child Health. Human development.

According to Johnston, if a male contraceptive obtains FDA approval, pharmaceutical companies and investors in the sector will dedicate more resources to other drugs or products.

“We've been trying to get this done for a long time,” Johnston said. “I hope we are entering new territory.”

Other options in development

The company YourChoice Therapeutics also said at the conference in Boston that there is a small trial of 16 men in the United Kingdom that showed its non-hormonal pill YCT-529 was safe and had no side effects.

The pill works by blocking the receptor of the vitamin important for male fertility.

YourChoice plans a larger-scale trial, according to its chief executive, Akash Bakshi. “We're excited to see what happens next,” he said.

Three-quarters of 2,066 men responded that they would be willing to try new contraceptives, according to a 2023 survey published in the journal Contraception.