After decades of women carrying contraceptive responsibility, advancements in the development of male contraceptives could see products approved for use within the next few years, with the potential to shift the burden of birth control.

For all the freedoms that come with it, for decades, women have borne the brunt of the responsibility for birth control, subjecting themselves to painful medical procedures and hormonal side effects, all to avoid unwanted pregnancy.

There are significantly fewer options when it comes to contraception for men, who are limited to using condoms or, at the other end of the extreme, undergoing a vasectomy.

But the field is on the cusp of transformation, with new advancements in male contraceptives that could rebalance the burden of birth control and give men a more active role in family planning.

First FDA-approved hormonal contraceptive for men

Scientists at biotech company Contraline are behind two advanced-stage innovations taking different approaches to male contraception, both of which are currently progressing through clinical trials.

Its lead candidate, NES/T – a transdermal gel that combines nestorone and testosterone to suppress sperm production – is said to be the most advanced male contraceptive currently in development and is poised to become the first FDA-approved hormonal contraceptive for men.

Applied daily to the user’s shoulders, it systemically delivers the two exogenous hormones to reduce sperm count, while balancing the serum hormones, such as testosterone, of the patient to minimise side-effects.

A Phase 2b study on NES/T, led by the Population Council and the NICHD, on over 400 couples, most of whom used the gel for around 18 months, showed “encouraging efficacy in suppressing sperm levels to contraceptive thresholds, along with a favourable safety profile,” Kevin Eisenfrats, co-founder and CEO of Contraline, tells Femtech World.

“We believe NES/T will be transformational in getting men excited about using contraception.”

Full results from the trial are expected to be published later this year, and in July, Contraline announced its decision to exercise its exclusive option agreement to license NES/T from the Population Council.

A Phase 3 trial is expected to launch in 2026 to pave the way for regulatory approval within the next few years.

Eisenfrats described this as a “pivotal moment” not just for Contraline, but for the “future of contraception”.

“We’re proud to build on the decades of groundbreaking work by the Population Council and NICHD and carry this momentum into Phase 3 and beyond,” he said in a statement at the time.

“Long-acting, reversible birth control”

In the meantime, Contraline is also developing an alternative to the vasectomy in the form of ADAM, billed as the world’s first injectable hydrogel designed to provide long-lasting, non-hormonal, and reversible contraception for men.

Injected into the vas deferens, the same duct targeted during a vasectomy, the gel forms a “soft, flexible barrier” that blocks sperm rather than cutting or permanently sealing it. While NES/T works systemically and requires consistent application, ADAM is localised and takes a set-it-and-forget-it approach. Compared to hormonal methods, it simply blocks sperm in the vas, meaning the user won’t experience any systemic side effects.

Crucially, unlike a vasectomy, ADAM is not permanent, but is designed to last up to two years and be easily reversible.

The hydrogel degrades naturally after this time, mirroring the concept of how intrauterine devices (IUDs) are used in women. Contraline has also designed a ‘minimally invasive’ reversal procedure to remove the implant and restore fertility before its two-year lifespan, which has been tested in pre-clinical models and is set to be incorporated into upcoming trials.

The results from its first in-human clinical trial of ADAM, were published in April, demonstrating both safety and efficacy, with no treatment-related serious adverse events reported, and Contraline has now received full regulatory approval to initiate a Phase 2 (Early Feasibility) clinical study in Australia later this year.

While not intended to replace the role of condoms in protecting against STIs, ADAM could reduce dependence on hormonal birth control and is expected to have fewer side effects than female options such as IUDs.

“ADAM fills a major gap: it offers men a long-acting, reversible form of birth control that simply doesn’t exist today,” Eisenfrats says

“It also complements female contraception in couples who want to share responsibility. There is a strong chance that the ADAM procedure could have fewer side effects and, therefore, be more appealing than IUDs for women, especially given that most IUDs are hormonal.

Shifting the burden of responsibility

Beyond the medical potential of products like ADAM and NES/T, these developments in male contraceptives could pave the way for a cultural shift in how we think about contraception.

“ADAM opens the door for a fundamental shift in how we think about contraceptive responsibility,” says Eisenfrats.

“Historically, the burden has disproportionately fallen on women. This relieves some of the burden placed on women, while empowering men to be great partners and take an active role.

He adds: “Male contraception will also be an option for couples where the female can’t be on hormonal birth control. By enabling men to step forward with a long-acting, non-hormonal option, we help drive the larger goal of gender equity in family planning.”

Such significant shifts in societal attitudes take time, though, and for real change to happen, men will have to be willing to play a more active role in sharing the contraceptive load.

Contraline is keen to play a part in this, building a strategy around “open conversation, education and storytelling”.

“This means meeting people where they are, whether that’s online, in clinics, or through partnerships with healthcare providers,” he says.

“Our approach emphasises shared responsibility, not just a shift from one partner to another. It’s about creating a new narrative that contraception can and should be a mutual decision, and that men have a role to play in protecting their partner’s health and their own future.”

Promisingly, there has been “overwhelming interest” from men and their partners coming forward to participate in clinical trials, with over 19,000 currently on Contraline’s waiting list, Eisenfrats says. While in Australia, 1,500 men came forward to take part in a trial with only 25 places.

“The enthusiasm and demand we have seen from the patients and investigators involved in the trials have been unmistakable,” Eidenfrats adds.

“The world is ready for male birth control.”