This week, researchers at the National Institutes of Health’s Contraceptive Development Program announced promising results from a phase 2 trial demonstrating the safety and efficacy of a novel male birth control gel. The product contains testosterone and the synthetic hormone segesterone acetate (called Nestorone) that reduces sperm production is the cutting edge in male contraception options. Segesterone acetate is an ingredient of the Annovera vaginal birth control ring.
“The development of a safe, highly effective and reliably reversible contraceptive method for men is an unmet need,” senior researcher Diana Blithe, Ph.D., chief of the Contraceptive Development Program at the National Institutes of Health said in a press release. “While studies have shown that some hormonal agents may be effective for male contraception, the slow onset of spermatogenic suppression is a limitation.”
The study included 222 men who completed at least three weeks of daily treatment with the contraceptive gel. Men applied about a teaspoon of the gel once daily to each shoulder blade.
Most study participants (86%) reached sperm suppression, the threshold researchers deemed effective for contraception, by week 15, the researchers reported. Among those men, sperm production was suppressed at a median time of less than eight weeks of segesterone-testosterone treatment. Testosterone treatment alone decreases sperm production, with a median time of 15 weeks, but the addition of segesterone acetate both sped up the efficacy time, and lowered the dose of testosterone needed to suppress sperm production, researchers found. With the daily segesterone-testosterone gel regimen, blood levels of testosterone are kept in the physiologic range to maintain normal sexual function, according to the press release.
While this study shows initial results that are promising, the study will continue to test the contraceptive’s effectiveness, safety, acceptability and reversibility of contraception after treatment stops.
U.S. and global surveys have found that men are willing to use contraception, associate professor of obstetrics and gynecology at the University of Southern California Dr. Brian Nguyen, one of the investigators on the gel clinical trials, told NBC News.
“By and large, they always say they’d be interested.”
But whether or not this option will make it to store shelves eventually depends on support of ongoing research and development. Drug developments can range from $1 billion to $2 billion, according to the Congressional Budget Office, and as of yet, this research project has no commercial partner to assist with costs.
“No pharmaceutical company is willing to put up money to develop a drug if there are not people who are going to take it,” Mills said. “It’s very concerning and, frankly, testimony to the sexism present in the drug development that it has taken so long to still not have an FDA-approved drug for male birth control," Jesse N. Mills, clinical professor of urology and director of the men’s clinic at UCLA told The Washington Post.
