Trial Data Shows ‘IUD for Men’ Is Effective for 2 Years

Contraline — a trailblazer in the nascent male contraceptive market — released promising new trial data on Thursday showing that the company’s contraceptive hydrogel has demonstrated safety and efficacy in the first two trial participants to reach the two-year mark.

In November 2022, Virginia-based Contraline became the first company to ever implant a male contraceptive gel into humans in a clinical trial. By now, the gel has been implanted into the vas deferens of 25 men — and the initial trial data looks good.

Contraline’s trial is being conducted across three medical centers in Australia. When it began, CEO Kevin Eisenfrats told MedCity News that the company’s contraceptive product, named Adam, is sometimes referred to as the “IUD for men” because it seeks to be a long-lasting yet reversible birth control method. 

That’s where the analogy stops, though, because Adam is nonhormonal and comes in gel form. But similar to an IUD, the gel can be implanted at a quick doctor’s office visit. 

Using a noninvasive, no-scalpel method, the doctor injects the hydrogel into the patient’s vas deferens. Once sperm is blocked from traveling through the vas deferens, a man does not produce sperm in his ejaculate, and is therefore unable to fertilize an egg.

The office procedure is conducted under local anesthesia and takes less than 20 minutes, Eisenfrats said.

Contraline has been keeping a close eye on its trial participants and plans to do so for the next couple years, he stated. So far, there have been no reported cases of any serious adverse events. Some patients have reported things like light bruising or swelling in the couple days following their procedure, but these cases have been mild and went away quickly, Eisenfrats explained.

Now that two trial participants have shown zero sperm count throughout 24 months, Contraline is proving the duration of its product’s intended effectiveness, he added.

“The idea for Adam has always been that this could be the IUD for men, and all of our market research supports something that lasts one to two years. Ideally, men could get this procedure every couple of years. That’s the goal, and now we have data to actually support that it’s possible,” Eisenfrats declared.

The main goal behind Contraline’s first in-human trial was to prove Adam’s safety and determine the optimal amount of hydrogel needed for maximum efficacy. The company is approved to begin its next trial — which will focus on proving Adam’s reversibility — in Australia, and it is working with the FDA to get permission to start implanting its gel in men in the U.S. as well, Eisenfrats said.

Generating data that can prove the gel’s reversibility will hopefully be Contraline’s next big milestone, he noted.

“Reversibility is sort of everything — it’s the difference between this product being a vasectomy alternative and it being the IUD for men, which is something that tens of millions of guys would be interested in using. The vast majority of men, especially those who are younger or are not family-complete, want to have children in the future or might want to have children in the future. Those guys all care about reversibility,” Eisenfrats explained.

The product is reversible in two ways, he pointed out — natural biodegradation over time or early removal through a minimally invasive procedure.

Eisenfrats appears to be correct in his assertion that hoards of men are interested in a product like Adam hitting the market. When the company began advertising for its Australian trial, it intentionally made the application survey lengthy and full of detailed questions so it could weed out anyone who wasn’t serious about wanting to try the gel, Eisenfrats said. Even so, more than 1,500 men completed the application. 

Eisenfrats noted that these men came from various walks of life — some were in their early 20s, some were middle-aged, some were in long-term relationships, some were single, some were childless, and some had already become fathers.

Contraline is still in discussions with the FDA about U.S. trials, but Eisenfrats said the company is aiming to earn Adam’s approval by the end of 2028. He added that Australian approval may come sooner, depending on regulatory pathways.

Photo: Contraline