Image: Contraline

In a significant development in male reproductive health, medical device company Contraline has announced early positive results from the first-in-human clinical trial of its novel male contraceptive product, ADAM. This marks a notable advancement in male contraception, a field that has seen little innovation since the introduction of the vasectomy.

Contraline, a venture-backed company, has introduced ADAM, an injectable, biocompatible hydrogel designed for implantation into the vas deferens to obstruct sperm transport. Unlike previous vas-occlusive contraceptives, ADAM is inert, non-permanent, and reversible, setting it apart as a pioneering solution in the sector. The current trial outcomes signify the successful transition of a non-hormonal male contraceptive into human clinical testing, demonstrating both the safety and efficacy of ADAM.

The trial was conducted across three sites in Australia—Melbourne, Brisbane, and Wollongong—successfully implanting the product in 23 participants. The procedure, which can be administered under local or general anesthesia, has reported a 100% successful implantation rate. The trial enlisted healthy males aged 25-65 who were suitable for vasectomy, with over 1,500 expressing interest in participation.

Within 30 days post-implantation, ADAM exhibited a 99.6-100.0% reduction in motile sperm count, aligning its efficacy with that of vasectomy. Moreover, there have been no significant adverse events reported, affirming the product’s safety profile. The trial’s Data Safety Monitoring Board has endorsed the continuation of the study without modifications.

“I am pleased with the early results we are seeing from the trial; it is exciting to see the preliminary outcomes showing ADAM is safe and effective. The level of participant interest we are seeing shows that there is a major need for this type of contraception, and I am excited to continue working with Contraline in the development of the device.” said Dr. Peter Chin, Urologist and Associate Professor at the University of Wollongong, and an investigator in the study.

“We are thrilled to share these positive results which we believe take us one step closer to transforming the contraceptive landscape. This trial and the data presented are a clear indication that ADAM is safe, effective, easy to use, and in-demand. The fact that we are seeing such dramatic reduction in sperm counts and motility, without compromising on safety, suggests that it is possible to achieve similar levels of efficacy as long-acting female contraceptives like IUDs. Ultimately, I’d like to make ADAM become a “no brainer” for men when it comes to considering their options for contraception,” said Kevin Eisenfrats, Co-Founder and CEO of Contraline.

As patients continue to be monitored for long-term effects, Contraline is preparing for an Investigational Device Exemption (IDE) submission in 2024, which will pave the way for further trials in the U.S. The company, founded in 2015 by Eisenfrats and Dr. John Herr, aims to offer a long-lasting, safe, and effective contraceptive solution for men, contributing to greater reproductive equity.

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