Trials have shown that an implanted, non-hormonal male contraception can survive for at least two years.
By implanting a water-soluble hydrogel in the sperm ducts, the contraceptive, called Adam, stops sperm from combining with semen.
According to the product's manufacturer, Contraline, the method provides a reversible substitute for condoms and vasectomies since the hydrogel is designed to decompose in the body over time, regaining fertility.
Details of Contraline's phase 1 clinical experiment have been made public. It shows that Adam can effectively prevent sperm release for 24 months, and that none of the two individuals who have reached this stage of the trial had any sperm in their semen. Furthermore, it said that no significant adverse events had been noted.
"The need is for a two-year-long, temporary or reversible male birth control, which is why this is so exciting. Our objective has been to develop a male contraceptive for that duration from day one. Kevin Eisenfrats, the founder and CEO of Contraline, said, "And we have the first data to show that that's possible."
According to Eisenfrats, the clinical trial's 25 participants were recruited at various times, and more findings are anticipated. He went on to say, "It's excellent proof of concept."
According to Eisenfrats, the patient was kept awake for the about ten-minute minimally invasive operation that included the insertion of the implant and the application of local anaesthetic.
Although Eisenfrats noted that some earlier implants have utilised materials that did not decompose in the body, Adam is not the first male contraceptive under development that works by blocking the sperm ducts (vas deferens). According to him, there was little evidence to suggest that fertility was restored after their removal, and there were worries that the implants would permanently sterilise the vas deferens and induce scarring.
Data on the implant's reversibility is not included in the Adam clinical trial findings, which have not yet been published in a peer-reviewed journal. Eisenfrats said that the hydrogel had a predictable lifetime and that animal tests had shown that it degraded with time, with studies using lower dosages in males showing a shorter duration of effectiveness.
According to Eisenfrats, "the way to think about this is sort of like the IUD [intrauterine device] for men." guys might then decide whether to have another implant after two years. The group is developing a process to make "on-demand reversal" possible. According to Eisenfrats, men may utilise sperm testing at home to determine whether the contraception was still working.
According to Contraline, a phase 2 clinical research with 30 to 50 people is anticipated to start later this year in Australia.
The results were welcomed by Prof. Richard Anderson, a specialist in hormonal male contraception at the University of Edinburgh. "It's amazing that this appears to be something that works, which is fantastic," he said.
"Both hormonal and non-hormonal approaches are currently in advanced clinical development, which may put us in a far better position than we were in the past to actually get something on the market that men can actually use."
However, Anderson and Professor Jon Oatley of Washington State University said that it was still unknown how long a single implant would endure and that no data had yet been made public demonstrating the Adam implant's reversibility.
While Oatley said that the long-term effects of blocking the vas deferens were unclear, Anderson added that it had not yet been shown that the implant could be removed.
According to Oatley, there may not be much acceptance of the Adam implant, despite the fact that it may be a powerful male contraceptive alternative. "I think that most men would prefer a pill or patch to surgery if they had to choose between pill, patch, injectable, or surgery," he said.
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