In the palm of your hand, it looks like a glop of hair gel. But this goo could one day revolutionize the reproductive health landscape by being the first male birth control to hit the market.
On Sunday, we got one step closer to that reality. Scientists with the National Institutes of Health’s Contraceptive Development Program announced encouraging results from a phase 2 trial demonstrating the safety and efficacy of the drug.
“The development of a safe, highly effective and reliably reversible contraceptive method for men is an unmet need,” said senior researcher Diana Blithe, Ph.D., chief of the Contraceptive Development Program, said in a statement. “While studies have shown that some hormonal agents may be effective for male contraception, the slow onset of spermatogenic suppression is a limitation.”
In the trial, more than 220 participants aged 18 to 50-years-old successfully reduced their sperm production with minimal side effects. The phase 2b trial aimed to reduce sperm production in patients to up to 1 million per milliliter, putting it well below the threshold of 15 million to 200 million deemed necessary for a man to be fertile. The product — which lowers sperm count with a combination of testosterone and a synthetic hormone called Nestorone (segesterone acetate) — succeeded for 86% of trial participants. Patients applied 5 milliliters of the drug combo between their shoulder blades every day for a year-and-a-half.
The research, which was presented at the Endocrine Society’s annual meeting in Boston, has yet to be peer-reviewed or published in a journal. More research is needed before the drug is finally approved and becomes available for the market.
There are currently no male contraceptives that are approved by the U.S. Food and Drug Administration. Indeed, because it is difficult for pharmaceutical companies to receive funding of this research, only a handful of previous drugs have even reached the clinical trial phase. Experts hope the latest advances will move the ball forward.
“We’ve been pushing for hormonal male contraceptives for 50 years, but there isn’t enough money available to really drive something through a very large phase 3 trial,” Daniel Johnston, chief of the National Institute of Child Health and Human Development’s Contraception Research Branch, told NBC News. Now that this research succeeded, they believe it will be easier to convince other investors to have faith in them. “We’ve been chasing this for a long time. I hope we’re entering new territory," Johnston added.
