The first long-lasting but reversible male contraceptive method, known as “the IUD for men,” is advancing and its commercialization could be a reality, at least in the United States, in a couple of years. The biotechnology company Contraline has published the first data from the clinical trial it is carrying out in Australia with Adam, a hydrogel that is injected through the scrotum to block the passage of sperm, and they are promising.
Doctors at the three Australian centers where the study is being carried out have already successfully implanted the hydrogel in the vas deferens (the pair of tubes in the male reproductive system that transport mature sperm) of 23 men and, after 30 days of Upon insertion, the gel had reduced the number of moving sperm by more than 99% with no serious side effects reported.
The product is implanted in the doctor’s office, with local anesthesia, in a non-invasive, scalpel-free procedure that lasts less than 20 minutes. According to the information provided by the company, some patients suffered minor bruising or swelling in the two days after the injection, but they assure that in all cases it was mild discomfort that disappeared quickly.
And the effectiveness results are relevant. “We are seeing phenomenal results in terms of sperm reduction, count and motility, which means that it is a very effective male contraceptive” because it prevents the man from producing sperm in his ejaculate and the egg cannot be fertilized, he said. assured Kevin Eisenfrats, co-founder and CEO of Contraline.
Eisenfrats is convinced that there is a clear demand for a product like Adam, non-hormonal, long-lasting and reversible, and proof of this, he explained, is that when the company announced its clinical trial more than 1,500 men completed the application for testing despite that it was accompanied by a long survey full of detailed and personal questions to ensure that only people who were truly interested participated.
Furthermore, those interested presented very varied profiles: from twenty-somethings to middle-aged men, both single and people with a stable partner, with children and without children…
This first clinical trial of efficacy and safety in humans will be completed next month when two more men have undergone the gel insertion procedure and, in parallel, Contraline is already preparing another for this same year aimed at testing the reversibility of the treatment.
The gel is designed to dissolve at the end of its useful life, so the men participating in the first trial will be followed for two years to determine how long it takes to disappear but, at the same time, in anticipation of there being people who want to regain their fertility before that time, Adam’s developers want to demonstrate that the procedure can be safely reversed.
“Men want to know that they can remove the gel at any time, that their fertility will return to normal levels, and that the reversal procedure is simple, so we are starting to do a small proof of concept specifically on reversibility that will begin in mid- 2024,” Eisenfrats said in statements reported by MedCity News.
The company has tested the reversibility of the gel in dogs and has verified that sperm count and quality recover after removing it. And now a second trial will test this on-demand reversibility in humans, although the initial gel implantation trial only included men who declared they did not want to have children.
The next step, according to the company, will be to request an investigational device exemption from the FDA before the end of the year in order to begin the broader clinical trials required for the contraceptive to be approved and marketed in the United States. According to Contraline officials, “given that pivotal trials will begin in 2025, we would like to obtain approval for Adam in 2026 or 2027.”
Its promoters are convinced that if their contraceptive product demonstrates the effectiveness they anticipate, it could change the rules of the game in sexual relations “ensuring that contraception is a shared responsibility between couples.”
But not all reproductive health experts see it that way. Many gynecologists are convinced that women, except those with a stable partner, will want to continue controlling contraception themselves and will not risk having unprotected relations with someone they have recently met because they say they do not ejaculate sperm.