- Ongoing research presented at the Endocrine Society’s annual meeting shows promise for a new male contraceptive option.
- The product, a gel, has shown effectiveness beyond what researchers initially expected.
- Experts are hopeful that this treatment, should it come to fruition in the long term, will provide another avenue for men to hold a larger role in reproductive health.
New research, presented at the Endocrine Society’s annual meeting on June 2, shows promise as a new contraceptive option for men.
The study, which is ongoing and included 222 participants and their partners, was an international effort that started in 2018.
The study has not yet been published in a peer-reviewed journal.
How the product works
The product, a gel, combines Nestorone (segesterone acetate) which suppresses sperm production by creating what researchers have called “a feedback loop” in the brain, and testosterone, which is required in order to maintain a person’s typical function. The men applied the gel once daily to each shoulder blade.
Study author Diana Blithe, PhD, the chief of the contraceptive development program within the National Institute of Child Health and Human Development, says that this research, which was delayed due to the COVID-19 pandemic, is a source for optimism, not just for the participants, but for their partners.
“What I think is not clearly recognized, especially when I read comments from some of these articles that are being [put in the] press is how much it means to the women who are in this trial with their partners, because they get to spend a year off birth control that they weren’t real happy with to begin with. And it’s quite a burden lifted from them to be able to have this, you know, sort of rest period.”
The study followed participants as they applied the gel daily, with 86% of participants seeing their sperm count suppressed below the threshold identified (lower than one million sperm per milliliter) after 15 weeks, 64% after 9 weeks, and 21% after just 5 weeks, much faster than Blithe and her team anticipated.
Andrew Y. Sun, MD, Director of Men’s Health at Urology Partners of North Texas and an associate professor of medicine at Texas Christian University’s Anne Burnett Marion School of Medicine, says that this research has to be viewed in the context of America’s recent reduction in reproductive rights and a corresponding uptick in vasectomies.
“The topic of male contraception comes out [in conversation with patients] a lot. Especially, I think, with recent legal changes, especially in certain states here in America, this has become an even bigger issue as people are trying to basically find easier and more accessible ways to achieve contraception. Historically, unfortunately, that always fell on the women.”
The use of testosterone therapy, which has seen an uptick in the US in recent years for all manner of reasons, does come with the side effect of reducing sperm production, but that process is measured on the scale of months rather than weeks.
How this could help
Beyond its as-directed effectiveness, one of the biggest barriers to any contraceptive is regular use. Blithe says that the response from the study’s participants was broadly positive and that this bodes well for future uptake.
“My favorite comment about acceptability is when the men finished the study and asked if they can re-enroll, they really liked it, they would stay on it if they could. And that’s a real endorsement for the product, because they’ve been at it for 20 months and they still want to keep going.”
Blithe sees this gel as complimenting other products on the market that were originally created with the hope that they could act as a male contraceptive, specifically SpermCheck and SpermCheck Vasectomy, and allow patients to get a better understanding of their sperm production at home.
Once the study has been finished, which is expected to complete enrollment by the end of the year, and once the final analysis has been done, Blithe and her team will turn their attention to identifying—alongside the FDA—an acceptable pathway for a phase three clinical trial. Once a phase three clinical trial is complete, the FDA can make a determination about granting the new therapy access to the market.
