Male non-hormonal contraceptive implant shown to work for 24 months in trials
A new male contraception has been shown in trials to last for at least two years, in a critical milestone moment.
The implantable, non-hormonal male contraceptive, known as Adam, is a water-soluble hydrogel that is implanted in the sperm ducts, preventing sperm from mixing with semen.
The hydrogel is designed to break down in the body after a set period of time, restoring fertility, which Contraline, the US-based company behind the product, has said makes it a reversible alternative to condoms and vasectomies.
In phase one of its clinical trial, Contraline found that ADAM could successfully block the release of sperm for 24 months, with no sperm detected in the semen of the two participants who have so far reached this time point in the trial. The firm added that no serious adverse events had thus far been recorded.
Dr Alexander Pastuszak, Contraline's chief medical officer, said: 'Our goal was to create a male contraceptive option lasting two years, responding directly to consumer needs.
'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 25 participants in the clinical trial were enrolled at different points in time, with more results expected to follow, according to The Guardian. The implant was inserted via a minimally invasive procedure that took ten minutes and used local anaesthetic, meaning the patient remained awake.
The Adam Study will be presented at the American Urological Association meeting on 26 April, as the contraception company announced it has received full regulatory approval to initiate its phase two clinical study in Australia, set to begin in the third quarter of 2025.
Contraline described this approval as a 'major milestone in the development of long-lasting, reversible male contraceptives, paving the way for accelerated progress and global momentum toward much-needed innovation in reproductive health'.
It said the study would build on the promising safety and feasibility results from the First-in-Human trial.
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