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Hormonal health

Science edges towards breakthrough in male contraception

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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.”

Hormonal health

Man City launch female athlete health education platform

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Manchester City has launched a female athlete health platform covering menstrual, pelvic and breast health, as well as nutrition.

The Her City website is designed for the club’s women’s first-team players, coaches, support staff, academy players and parents.

Manchester City says the platform is the first of its kind in the Women’s Super League and was developed over two years.

The project was led by director of performance services Emma Deakin, physical performance scientist Rosie Anderson and PhD student and first-team nutritionist Sarah Malone.

It grew out of PhD research into menstrual, pelvic and breast health and nutrition, with the team seeking to turn that work into an online educational resource.

The website divides the four areas into separate sections and provides peer-reviewed information that the club says has been critically analysed by experts.

Content will continue to be reviewed and updated as further evidence emerges.

Resources include posters, visual explainers, audio materials and downloadable educational content, with information tailored to different groups including players and parents.

The platform aims to improve knowledge, develop critical analysis skills and strengthen communication within football and at home.

It also includes material to help users assess misinformation they encounter on social media or elsewhere.

A confidential contact form allows users to raise concerns or ask questions directly of experts at Manchester City.

Parents of academy players can also access the platform, with resources intended to help them support their children during a key phase of their development.

Manchester City said its longer-term aim is to make the platform available to all women working across City Football Group.

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Menopause

NIH awards multi-university team over US$4 million to improve women’s health

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Michigan State University researchers are launching a novel project to transform how medications are developed and prescribed for women.

A US$4.6m award will fund computer models designed to predict how hormonal changes affect the way medicines move through and act in women’s bodies.

The funding is the first instalment of an award worth up to US$12.8m over three years, supporting work intended to account for hormonal changes throughout women’s lives.

Researchers plan to examine factors including menstrual cycles, pregnancy, contraceptive use, menopause and hormone replacement therapy, which can affect responses to medicines.

Teresa K. Woodruff, lead investigator on the project, said: “Because female hormone levels are constantly shifting, precision medicine allows us to map out these complex interactions.

“This NIH-backed initiative will create the first computationally driven clinical tool designed to guide medical care across every stage of a woman’s life.”

The project is led by researchers at Michigan State University and funded by the National Institutes of Health, with collaborators from Rutgers, Emory, Tulane, the University of Colorado Anschutz, the University of Michigan and the University of Utah.

Thirteen researchers will develop computational models to predict how changes in female hormones influence the way medicines move through and act within the body.

The work is part of the NIH Computational Modeling of Hormone Homeostasis Initiative, which is awarding US$21m nationally to support research into sex-specific hormonal biology.

The team plans to use artificial intelligence to digitise and organise more than 40 years of hormone research data in a publicly accessible database.

Researchers will also develop a standard computer model of a 28-day menstrual cycle, alongside models of how hormones regulate organs and tissues involved in processing nutrients, including the liver, muscle and fat.

Real-world patient data will then be used to expand the models to represent groups including women going through menopause or taking birth control, as well as women with conditions such as diabetes and obesity.

The project will also use three-dimensional human tissue models and lab-grown organoids, including liver, muscle and ovarian tissue, to test and refine the computer predictions.

Researchers plan to examine medicines including metformin, insulin and GLP-1 drugs, with the aim of developing tools that could help clinicians tailor doses and avoid harmful side effects.

Qiang Zhang, associate professor at Emory University, said: “Empowered by AI, novel assays and legacy human data, we will develop mechanistically based computational models of female physiology that can make translational, quantitative predictions for women’s responses to metabolic therapies.”

The researchers said the work could help address differences in how women respond to treatments for metabolic conditions including obesity, type 2 diabetes, cholesterol imbalances and thyroid disorders.

Nanette Santoro, professor at the University of Colorado Anschutz and president of the Endocrine Society, said: “Women experience large shifts in reproductive hormones at several points in their lifespan: puberty, pregnancy and menopause.

“During reproductive years, women also undergo profound day-to-day changes in reproductive hormone levels, giving them a markedly different endocrine backdrop than men.

“Using state-of-the-art computational technology to examine how these changes interact with commonly used medications is a critical pathway toward supporting life-course women’s health.”

The project team said its computer models and data will be made freely available to researchers and healthcare professionals when the work is completed.

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Menopause

High street bakery chain Gail’s reveals menopause plan

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Gail’s has unveiled a menopause action plan offering new workplace support to thousands of staff ahead of legal reforms due in 2027.

The high street bakery chain will offer new benefits including 24/7 digital GP access and a new employee assistance programme, according to The Times.

It will also explore new online training for staff, including specific training for management.

Gail’s people director Miranda Burgum told The Times: “All we’re trying to do is talk freely and for it not to be a forbidden subject. It’s helping our managers and teams understand that this isn’t a taboo.”

“We’re going to develop the education with our managers, so it will be threaded through all our policies

“It will look at induction training, it will look at the types of people we need to make sure that we make reasonable adjustments for.

“And if somebody needs some sort of risk assessment, we’re going to be looking at [that].”

The move comes ahead of reforms due to be introduced in spring 2027 under the Employment Rights Act.

UK employers with 250 or more employees will be legally required to publish and update official menopause action plans.

The plans are intended to support employers to take effective action to improve workplace gender equality and support employees experiencing menopause.

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