A new male birth control option could be even more attractive to potential users than expected. Preliminary research published Sunday suggests that NES/T – a gel applied once daily to the shoulders – can effectively suppress men’s fertility within weeks.
NEST is the abbreviation of the two main ingredients it contains, nestorone and testosterone. Nestorone, also known as segesterone acetate, is a synthetic version of progesterone, a hormone that plays a major role in regulating pregnancy and other reproductive functions. Nestorone and similar drugs are already used as hormonal contraceptives in women. When administered to men, the drug lowers the levels of hormones in the testicles responsible for male fertility, including testosterone, which then leads to low sperm counts. But it also reduces testosterone circulating in the blood, which can counterproductively reduce men’s libido, among other adverse effects. By reintroducing synthetic testosterone via the gel, the aim is to maintain stable hormone levels in men’s blood, thereby ensuring temporary sterility and minimizing side effects.
The gel is being developed with the help of several organizations, including the U.S. government’s National Institute of Child Health and Human Development (NICHD), which is part of the larger NIH. It is currently being tested in a larger-scale Phase IIB trial, involving approximately 400 couples. This trial is still ongoing, but researchers have already started looking at some of the available data, which has yielded encouraging results. In summer 2022, for example, Diana Blithe, head of the NICHD Contraceptive Development Program, reported that the effectiveness rate of NES/T gel so far appeared be comparable, if not superior, to hormonal contraceptive options for women.
In this new research, presented this weekend at ENDO 2024, Blithe and his team examined the timing of NES/T gel’s effectiveness. Based on other studies of hormonal contraception in men, Blithe and his team expected that most men’s sperm counts would begin to be sufficiently suppressed between 12 and 15 weeks. But they were pleasantly surprised to find how much less time it took many of their subjects.
Of the 222 participants whose sperm was checked within 15 weeks of starting treatment, 86% achieved overall suppression of their sperm counts. In five weeks, about 20% were removed; by the eighth week, 52% was removed and by the ninth week, 62% was removed. And among those who were repressed, the median duration of repression was only eight weeks. Because Blithe’s team didn’t expect these results from the start, many participants did not have their sperm checked between weeks four and eight. It is therefore possible that the average duration of deletion was even shorter than that calculated.
“We are really happy with this result. And we think that will make the gel more attractive to people who maybe didn’t want to wait three months for it to reach effectiveness,” Blithe told Gizmodo over the phone.
The results are still preliminary and it will take more time for the full Phase II data to be collected and analyzed. But Blithe and his team have been encouraged by everything they’ve seen so far. According to the team’s initial evaluations, the gel appears to be both effective And safe, with minimal side effects for men who take it.
“I think there’s been a lot of bad publicity about hormonal methods for men, which makes the expectations quite scary for people, but maybe that works to our advantage. People sign up and realize, “Oh, nothing bad happened, that’s great.” » said Blithe. “We are quite pleased with the limited side effects we observed.”
Blithe and his colleagues are expected to meet with the FDA next year to discuss the steps needed to launch a larger Phase III trial and are still looking for a commercial partner to help them bring the NES/T gel to market. So it will be at least a few more years before men can potentially get their hands on the product. But for now, the the future of male birth control still looks shiny.
News Source : gizmodo.com
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