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New Trial Confirms Safety and Effectiveness of Male Birth Control Gel

For a year and a half, 24-year-old Logan Whitehead applied a clear gel to his shoulders every morning, waiting for it to dry before starting his day.

“It was basically like a hand sanitizer solution,” said Whitehead, from Torrance, California. “It smelled and looked like hand sanitizer.”

However, this gel wasn’t hand sanitizer. It was a hormonal solution designed to block Whitehead’s sperm production, serving as a form of male birth control.

Whitehead participated in a phase 2 trial for this gel until this past winter. The product, containing testosterone and a synthetic hormone called Nestorone, aims to reduce sperm production and is the most advanced among new male birth control options.

If approved by the FDA, Whitehead said he would continue using it, especially after seeing his partner struggle with existing female birth control options.

“The gel was such an easy process,” he noted. “It was like taking a daily pill.”

Whitehead experienced minimal side effects, including some upper back acne and possible weight gain, which could have been due to his new sedentary job.

Hormonal Gel Trial Shows Promise

At the Endocrine Society’s conference in Boston on Sunday, NIH researchers presented promising phase 2 trial results for the hormonal gel. The trial included 222 men, aged 18 to 50, who applied 5 milliliters of the gel to each shoulder blade daily.

The trial’s second part is ongoing, but initial findings showed the contraceptive worked faster than expected. Diana Blithe, chief of NIH’s Contraceptive Development Program, reported that 86% of participants achieved sperm suppression (up to 1 million sperm per milliliter of semen) after 12 weeks, with effective contraception averaging eight weeks.

In contrast, normal sperm counts range from 15 million to 200 million per milliliter. This faster suppression is encouraging, especially since past attempts took longer and required higher doses of testosterone, leading to more side effects. The combination of testosterone and Nestorone in the gel works more quickly and requires less testosterone.

Nestorone, a progestin used in vaginal ring contraceptives, and testosterone together help suppress sperm production without affecting sex drive or causing significant side effects. Men in the trial maintained normal sexual function with low testosterone levels.

Researchers are now monitoring the gel’s effectiveness in preventing pregnancy. Male participants, who must be in committed, monogamous relationships with consent from their female partners, use the gel as their sole birth control method and have sex at least once a month for a year. Periodic sperm count tests predict fertility, with low counts indicating slim pregnancy chances.

Despite decades of attempts, no federally approved male birth control drugs exist, with few advancing to human trials. The primary barrier has been insufficient funding for expensive advanced human trials.

“We’ve been pushing for hormonal male contraceptives for 50 years, but there isn’t enough money available to drive a large phase 3 trial,” said Daniel Johnston, chief of the NICHD’s Contraception Research Branch.

Johnston believes FDA approval of one male birth control drug could attract more investment for other products. “We’ve been chasing this for a long time,” he said. “I hope we’re entering new territory.”

Nonhormonal Options in Development

At the same Boston conference, YourChoice Therapeutics reported that its nonhormonal pill, YCT-529, showed safety and no side effects in a small U.K. trial involving 16 men. This San Francisco company’s pill works by blocking the vitamin A receptor crucial for male fertility.

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