Male Birth Control Gel Shows Promise in Clinical Trials

The idea of effective male birth control could finally become a reality as a gel shows promise in preventing pregnancy. The National Institutes of Health’s (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development funded these groundbreaking clinical trials.

A press release by the Endocrine Society reveals that a new male contraceptive gel suppresses sperm production faster than similar hormone-based methods for men. The ingredients of the groundbreaking medication include two hormones: segesterone acetate (Nestorone), and testosterone. Segesterone acetate is an ingredient in the Annovera vaginal birth control ring.

“The development of a safe, highly effective and reliably reversible contraceptive method for men is an unmet need,” said Diana Blithe, Ph.D., chief of the Contraceptive Development Program at NIH in Bethesda, Maryland. “While studies have shown that some hormonal agents may be effective for male contraception, the slow onset of spermatogenic suppression is a limitation.”

The Eunice Kennedy Shriver Insitute studied 222 men who used the gel for three weeks daily. The medicated gel was applied once daily to each shoulder blade. According to Blithe, “The threshold deemed effective for contraception was 1 million or fewer sperm per milliliter of semen.”

The men were subsequently tested for sperm suppression. Of the men studied, 86% reached the lower sperm count goal at just over four months of use. The Phase 2 trial control group included males aged 18 to 50. 

According to the Food and Drug Administration, these types of medication trials typically involve hundreds of participants in Phase 2. Each Phase 2 trial can last from several months to two years.

This is not the first time a type of male birth control has been explored. In early 2023, Complex reported that a drug that could temporarily hinder fertility was tested on mice and was successful.

In mice, this period of infertility kicked in within 30 minutes of a single dose. Subsequently, fertility in the rodents was confirmed to have been fully restored by the next day after taking the drug. It has not been determined when human subjects would be studied with that same drug.