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The first female oral contraceptive was approved by the FDA in 1960. In the 65 years since its inception, it has become a commonly used drug. 

The same cannot be said for the male pill, which still does not exist despite decades of research and trials.

Speaking with Univadis Spain, a Medscape Network platform, Isabel M. Silva Reus, MD, Sexual and Reproductive Health Center of Villena, Alicante, Spain, said, “There is a gender gap. Historically, contraception has been the responsibility of women because they are the ones who become pregnant, and men wash their hands of it. This has been a burden over the years. Drug companies have also shown a sexist bias and have focused on women because if female contraception works, why research male contraception?”

Hormonal Gel

The most recent trialis NES/T, a gel developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The gel was applied once daily and absorbed through the skin of the shoulder and upper arms.

The product contains testosterone and nestorone, which are synthetic analogs of progesterone that suppress sperm production. The study data showed that the gel reduced sperm concentration to 1 million per milliliter or less in 88.5% of men, with minimal side effects. Therefore, it can be further studied as a transdermal hormonal male contraceptive. 

“The trial was in phase 2 and is now in phase 3. It also causes side effects such as acne, hair loss, weight gain, and apparently increased libido,” said Silva Reus.

Pills in Development

Recent surveys have shown a shift in men’s preferences for contraception. In the largest global survey of 12,435 men published in 2024, 61% said that they would consider trying new contraceptives. Silva Reus stated, “I have a young patient population, and when I ask younger men, most say they’d be willing to take a pill,” She added that men are more likely to accept pills than gels, which is why current studies are moving toward pills.

YCT-529, developed by YourChoice Therapeutics and currently in phase 2 clinical trials, blocks the retinoic acid pathway essential for sperm maturation. “It’s not a hormone. It blocks vitamin A receptors, so sperm are not produced,” Silva Reus explained. 

Preclinical data show that the compound inhibits fertility in male mice within 4 weeks of oral administration and reduces sperm production in a nonhuman primate model within 2 weeks, with no reported adverse effects. 

These results support the advancement of YCT-529 in human clinical studies.

Nonhormonal Research

Another line of research focuses on nonhormonal male contraceptives. According to a study published in Nature Communications, scientists in the United States have identified a compound, TDI-11816, that inhibits an enzyme essential for sperm motility by inactivating soluble adenylyl cyclase. “It shows 99% efficacy and would be taken 30 minutes before sexual intercourse,” said Silva Reus. To date, no male oral contraceptives or pills are commercially available.

Silva reported no conflicts of interest.

This story was translated from Univadis Spain.