Breakthrough: Faster-Acting Male Contraceptive Gel

A recent study found that a novel male contraceptive gel that combines testosterone and segesterone acetate, also known as Nestorone, lowers sperm production more quickly than comparable experimental hormone-based male birth control techniques.

ENDO 2024, the Endocrine Society’s annual conference in Boston, will feature a presentation of the results of an ongoing international phase 2b clinical trial on Sunday.

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

The study, which involved 222 men who finished at least three weeks of daily therapy with the contraceptive gel, is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. There were 74 mg of testosterone and 8 mg of segesterone acetate in the gel. One component of the Annovera vaginal birth control ring is estradiol acetate. Men use the gel on each shoulder blade once a day.

Early in the study, sperm count tests were obtained at 4-week intervals to measure for reduction of sperm production. According to Blithe, sperm counts of one million or fewer per milliliter of semen were considered effective for contraception.

By week 15, the majority of study participants—86%—achieved this sperm count, according to the researchers. After fewer than eight weeks of segesterone-testosterone therapy, the median, or midway, time of sperm production suppression was observed in those men. According to Blithe, previous research on male hormonal contraceptives administered by injection revealed that the suppression of sperm production took a median of 9 to 15 weeks.

“A more rapid time to suppression may increase the attractiveness and acceptability of this drug to potential users,” Blithe said.

The addition of segesterone acetate shortens the duration and reduces the dosage of testosterone required to suppress sperm production compared to testosterone alone, according to her. Testosterone therapy alone reduces sperm production, with a median period of 15 weeks. Blood levels of testosterone are maintained in the physiologic range by the daily segesterone-testosterone gel regimen to support normal sexual activity and other androgen-dependent activities.

The international phase 2b trial of segesterone-testosterone gel has finished its sperm suppression phase. The effectiveness, safety, acceptability, and reversibility of the contraceptive after treatment ends are still being tested in this study.

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