Today, almost all available birth control options are female contraceptives. Biotech company Contraline, however, claims that clinical trials for its non-hormonal and reversible male contraceptive have reached a critical milestone.
In a news release published today, Contraline announced that its male contraceptive, named ADAM, proved to be effective and safe 24 months into its first human clinical trial. While their clinical results have yet to be published in a scientific journal, the company plans to release additional data during the American Urological Association (AUA) meeting on April 26.
ADAM is a water-soluble hydrogel injected into the vasa deferentia—the two tubes in men that carry sperm from the testicles to the urethra—via a minor procedure. The implant blocks the sperm while still allowing ejaculation, and Contraline has been marketing it as a future, long-term, reversible alternative to condoms and vasectomies.
“Our goal was to create a male contraceptive option lasting two years, responding directly to consumer needs,” Alexander Pastuszak, Contraline’s Chief Medical Officer, said in the release. “These findings confirm that ADAM, our novel water-soluble hydrogel, can achieve the intended lifespan. We remain optimistic about its safety, efficacy, and reversibility, and its potential to give men and couples greater reproductive control.”
The milestone is based on two participants in the first human clinical trial showing azoospermia (no sperm in their ejaculate) at 24 months. In a previous news release, Contraline claimed that ADAM caused a 99.8% to 100.0% reduction in the number of moving sperm within 30 days of implantation.
These results “take us one step closer to transforming the contraceptive landscape,” Kevin Eisenfrats, co-founder and CEO of Contraline, said at the time. They suggest “that it is possible to achieve similar levels of efficacy as long-acting female contraceptives like IUDs. Ultimately, I’d like to make ADAM become a ‘no brainer’ for men when it comes to considering their options for contraception.” IUDs, or intrauterine devices, are small female contraceptive devices inserted into the uterus.
According to the recent news release, none of the participants have reported serious adverse events, or faced unexpected safety concerns. Researchers conducting the clinical trial will continue monitoring other participants at the 12-, 15-, 18-, and 21-month marks through lab and at-home sperm testing. Furthermore, Contraline has received full regulatory approval to start the study’s second phase.
However, Jon Oatley, a professor at Washington State University’s School of Molecular Biosciences, pointed out that there’s no public data yet confirming the ADAM implant is reversible, and researchers still don’t know the long-term effects of blocking the vasa deferentia, as he told The Guardian. Oatley also suggested that most men would prefer a contraceptive pill or patch over a surgery.
However, data from 2017 to 2019 shows that 10.4% of women between the ages of 15 and 49 used long-acting reversible contraceptives, such as IUDs or other contraceptive implants requiring procedures. That’s less than four points behind the pill’s 14%. If ADAM really does prove to be safe and effective, perhaps a significant number of men will also choose the long-term efficacy of an injection rather than the short-term usefulness of other contraceptives.
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