A new implantable, non-hormonal male contraceptive called Adam has been shown in trials to last for at least two years. This contraceptive is a water-soluble hydrogel that is implanted into the sperm ducts, effectively preventing sperm from mixing with semen. The company behind the product, Contraline, claims that this method provides a reversible alternative to both condoms and vasectomies. The hydrogel is designed to dissolve in the body after a specific period, allowing for the restoration of fertility.
Contraline has announced details of its Phase 1 clinical trial, which indicates that Adam can effectively block sperm release for up to 24 months. So far, no sperm has been detected in the semen of the two participants who have reached this milestone in the trial. Additionally, the company reported that no serious adverse events have occurred. “This is really exciting because our goal from the very beginning has been to create a two-year-long male contraceptive. There is a demand for a temporary or reversible male birth control option that lasts two years, and we now have the initial data to demonstrate that this is possible,” said Kevin Eisenfrats, the founder and chief executive of Contraline.
Eisenfrats noted that the 25 participants in the clinical trial were enrolled at different times, and more results are expected in the future. “It’s great proof of concept,” he added. The implant was inserted through a minimally invasive procedure that took about 10 minutes and used local anesthetic, allowing the patient to remain awake during the process.
Adam is not the first male contraceptive in development to block the sperm ducts (vas deferens). However, Eisenfrats indicated that some other implants utilized materials that do not break down in the body. He mentioned that there is limited data to demonstrate whether fertility is restored after the removal of these implants. Additionally, there are concerns that such implants could cause scarring of the vas deferens, potentially leading to permanent sterilization.
The results from the Adam clinical trial have not yet been published in a peer-reviewed journal and do not include data on the reversibility of the implant. However, Eisenfrats said the hydrogel had a predictable lifespan and had been shown to break down over time in animal trials, with work using lower doses in men revealing a shorter period of efficacy.
“The way to think about this is sort of like the IUD [intrauterine device] for men,” Eisenfrats said, adding that after a two-year period men could decide whether to get another implant. The team is working on a procedure to enable “on-demand reversal”. Eisenfrats said sperm tests could be used by men at home to check whether the contraceptive was still effective.
Contraline said it was expecting to begin a phase 2 clinical trial in Australia later this year involving 30 to 50 participants. Prof Richard Anderson, an expert in hormonal male contraception at the University of Edinburgh, welcomed the findings. “It’s impressive that this looks like something that does actually work, which is great,” he said.
‘We’ve now got hormonal and non-hormonal methods in advanced clinical development, which is potentially a much better position than we’ve been in previously in terms of actually getting something on the market for men to really use.” But Anderson and Prof Jon Oatley, of Washington State University, said at present no data had been released showing the reversibility of the Adam implant, and it remained unclear how long a single implant lasted.
Anderson also said it had yet to be shown that the implant could be removed, while Oatley said the long-term ramifications of blocking the vas deferens were unknown. Oatley said that while the Adam implant could be a strong contraceptive option for men, uptake may be limited. “Given a choice of a pill, patch, injectable or surgery, I believe that most men would choose pill or patch over surgery,” he said.
Source: theguardian.com
