A phase 2 trial has shown promising results for a gel-based male contraceptive, indicating its effectiveness in preventing unwanted pregnancies and its quick reversibility. This breakthrough may signal that reliable male birth control could soon be available at pharmacies.
The study, funded by the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, involved 222 men who applied the contraceptive gel daily for at least three weeks. The gel, applied to the shoulder blades, contained 8 milligrams of segesterone acetate and 74 milligrams of testosterone.
By the 15th week of treatment, 86% of participants had sperm counts below the threshold typically used to diagnose male infertility. This significant reduction in sperm count demonstrates the gel’s potential as an effective male contraceptive.
Dr. Diana Blithe, Ph.D., chief of the Contraceptive Development Program at the National Institutes of Health, explained the science behind the regimen. “Testosterone treatment alone decreases sperm production, typically taking about 15 weeks. However, the addition of segesterone acetate not only speeds up this process but also reduces the required dose of testosterone,” she noted. The gel regimen maintains blood testosterone levels within the physiological range, ensuring normal sexual function and other androgen-dependent activities are preserved.
While the current results are promising, further tests are necessary to examine the gel’s long-term effectiveness, safety, acceptability, and reversibility after treatment cessation. Nonetheless, the progress made so far is a significant step forward in the development of male contraceptives.
“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,” said Daniel Johnston, a senior colleague of Dr. Blithe, when speaking to NBC News. “We’ve been chasing this for a long time. I hope we’re entering new territory.”
The trial’s results were presented at the Endocrine Society’s annual meeting in Boston, though they have yet to undergo peer review. However, the findings have generated considerable excitement within the scientific community and among those advocating for more diverse contraceptive options.
Historically, male contraceptive development has faced numerous challenges, including financial constraints and the complexity of male reproductive biology. Unlike female contraception, which often involves targeting a single egg per menstrual cycle, male contraception requires the suppression of millions of sperm produced daily. This complexity has made it difficult to develop effective and reversible male contraceptives.
The gel-based contraceptive represents a novel approach that addresses some of these challenges. By combining segesterone acetate with testosterone, researchers have created a method that not only suppresses sperm production effectively but also maintains normal hormone levels, reducing the risk of side effects commonly associated with hormonal treatments.
As research continues, there is hope that this gel could become the first widely available hormonal male contraceptive, offering men more control over their reproductive health and providing couples with additional options for family planning. The success of the ongoing trials will be crucial in determining whether this contraceptive method can move forward to larger phase 3 trials and, eventually, become a mainstream option.
The phase 2 trial’s positive results mark a significant milestone in the quest for male contraception. With continued research and funding, the dream of a reliable, reversible male contraceptive may soon become a reality, transforming the landscape of reproductive health.
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