Male birth control shows promising results in human trial

Somewhere, King Arthur and the Knights of the Round Table are punching the air with excitement – because the holy grail may be near. On Sunday, at the Endocrine Society’s conference in Boston, researchers presented encouraging Phase 2 trial results for a male birth control treatment.

Gellin' like a fella

In the Phase 2 trial, 222 men applied 5 milliliters of a hormonal gel (the equivalent of a teaspoon) to each shoulder blade once a day.

The result? The gel, comprised of both Nestorone and testosterone, successfully lowered sperm count to the threshold deemed effective for contraception in 86% of men participating in the trial. It also accomplished this feat within eight weeks on average – sooner than the scientists expected and faster than the 9-15 weeks seen with male contraceptive injections.

• Combining Nestorone and testosterone in the new gel is meant to keep men from producing sperm without affecting their sex drive or causing other side effects.
• And so far, so good. The men in the gel clinical trial have shown low enough blood levels of testosterone to maintain normal sexual function, with minimal side effects.

Male BC has been a long time coming. A working female contraceptive, the birth control pill, was developed in the 1950s. But history is littered with failed attempts at creating a male contraceptive, in large part due to biology- and- funding-related challenges.

• Men make millions of sperm every single day, while, on the other hand, women’s ovaries typically release one mature egg per month – a far easier target for contraceptives.
• Plus, developing drugs is expensive work. The median cost to support a drug from R&D all the way through to FDA approval was $985 million between 2009-2018, according to a study published in the journal JAMA.

Looking ahead… The gel’s researchers are set to meet with the FDA next year about the steps needed to begin a larger Phase III trial. They’re also seeking a commercial partner to help bring the product to the market.

And, should it ever get to market, there could be some competition – other male birth control treatments are also in development. YourChoice Therapeutics announced over the weekend that it had completed a small male birth control trial in the UK (16 men) that indicates its nonhormonal male birth control pill is safe and free of side effects.

🚫👶 Bottom line: No male birth control treatment – not even the “testicle-bath" that won the 2021 Dyson Award for Engineering – has ever made it past human clinical trials. But that could soon change.