News
Science edges towards breakthrough in male contraception
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.”
Supermarket loyalty card data suggests more than a quarter of women buying menstrual products also buy pain relief at the same time.
The findings also suggest women in lower-income areas are significantly less likely to do so, pointing to disparities in access to over-the-counter pain relief across England.
The study was led by Dr Victoria Sivill of the University of Bristol and colleagues.
The authors said: “The study highlights the need for greater awareness and policy interventions to address the high prevalence of menstrual pain as well as socioeconomic dimensions of menstrual pain.
“Public health initiatives should incorporate menstrual pain relief as part of broader efforts to improve health equity.”
Researchers analysed anonymised loyalty card data from a major UK health and beauty retailer, covering 211m transactions by 3.4m people between 2006 and 2015.
The study examined how often shoppers bought menstrual products and pain relief in the same transaction, and compared this with a customer’s usual rate of buying pain relief.
It found that 26.7 per cent of customers who bought menstrual products also bought pain relief at the same time.
These customers were nearly four times more likely to buy pain relief when buying menstrual products than on other shopping trips.
As a check on the approach, researchers found the most common interval between consecutive menstrual product purchases was exactly 28 days, consistent with the average menstrual cycle.
Menstrual pain is common and can affect daily activities, including school and work attendance.
Regional income was the strongest predictor of menstrual pain purchases.
Customers in the lowest-income areas were 32 per cent less likely to buy pain relief at the same time as menstrual products than those in the highest-income areas.
The authors said lower rates of pain relief purchases in deprived areas are likely to reflect an inability to afford over-the-counter medication rather than lower rates of menstrual pain itself.
Co-author Dr James Goulding said: “It is wonderful that smart data research in the UK is able to bring issues which may have once been overlooked in scientific settings, such as the sheer scale and impact of menstrual pain, to light. This is well overdue.
Co-author Dr Anya Skatova said: “Like many women, I was aware of how common menstrual pain is, but the scale of painkiller purchases alongside menstrual products was still striking.
“Using shopping data, we can see just how widespread the need for pain relief really is. This kind of evidence helps make menstrual pain visible at a population level and provides a strong foundation for systemic change in how it is recognised, treated, and prioritised in public health.”
Women are still being failed by menopause care despite a surge in online advice, with experts saying symptoms are too often minimised or dismissed.
The researchers exposed a gap between the surge of menopause information available online and the quality of medical care women receive.
A team of anthropologists and psychologists explored the physical and emotional toll of menopause, including its impact on work and personal lives, through interviews with 60 women aged 45 to 61 between March and June 2021.
The findings were published in a new book, We Need to Talk About Menopause.
The interviews showed how women continue to “needlessly suffer” as they sort through misinformation from influencers, celebrities and so-called experts.
The authors said: “You would think in an age where humans are developing commercial space flight, self-driving cars, and AI personal assistants who can project movies onto the palm of your hand, we would understand more about menopause, something a little over half of the population is guaranteed to experience in their lives.”
The interviews revealed wide variation in women’s experiences of doctors.
Some felt they could have an open dialogue, while others said they were “shut down”, including being told they were too young for menopause.
One woman said she bled heavily for a year before she was taken seriously.
The authors said menopause is still poorly understood, with disagreement over whether it should be seen as a medical condition or a natural part of ageing.
There are more than 100 recognised symptoms, although some women experience none.
Among those interviewed, 78 per cent reported weight gain and redistribution, particularly around the belly area, which was resistant to diet and exercise.
Fifty-eight per cent experienced mood disturbances including anxiety, depression, irritability and unprecedented levels of rage.
Many women said they were blindsided by symptoms they had never known existed.
One participant said she only realised rage was a menopause symptom after seeing it mentioned in a television commercial.
Women also described severe memory problems and brain fog that colleagues mistook for incompetence, leading successful professionals to question their abilities at the peak of their careers.
Brain fog can include problems with concentration, memory and clear thinking.
According to Statistics Canada, 70 per cent of women turn to the internet as their primary source of menopause information.
The authors said this information vacuum has spawned a £14.7bn global “meno-tech” industry, with influencers, celebrities and telehealth companies offering products ranging from £98 creams to unnecessary blood tests.
They said: “The growth of interest in menopause has also been accompanied by a wave of unsubstantiated information.
“Many websites market expensive creams, supplements, and weight-loss schemes that promise to keep women youthful and attractive, with little evidence to support their claims.
“Reliable, accessible information about menopause and perimenopause is still lacking. Despite increased attention to the importance of physician training and the search for menopause specialists, the medical profession as a whole continues to provide limited support in this area.”
The authors also highlighted the effect of menopause in the workplace.
The House of Commons Women and Equalities Committee has warned that Britain is “haemorrhaging talent” because of menopause, with 14 million workdays lost each year, according to the Office for National Statistics.
Despite this, studies have shown 80 per cent of UK employers have yet to implement proper support measures for menopausal women.
Some women said simple workplace adjustments made a significant difference.
The Women and Equalities Committee (WEC) has warned against “financial half measures” on women’s health as the government published its response to the report.
Ministers launched the renewed Women’s Health Strategy in April after the committee’s March report concluded it was not convinced that the menstrual and gynaecological needs of young women and girls had been sufficiently prioritised in wider healthcare reforms.
It followed the committee’s 2024 “medical misogyny” report, which found women with painful reproductive health conditions such as endometriosis, adenomyosis and heavy menstrual bleeding were frequently finding their symptoms “normalised” and their “pain dismissed” when seeking help.
In both reports, MPs called on the government to recognise the benefits of increased investment in early diagnosis and treatment of women’s reproductive health conditions and provide additional funding needed to transform the support available to millions of women.
In its response, published on 26 May as a command paper, the Department of Health and Social Care outlined action on reducing gynae waiting times, ensuring procedures are conducted with women’s full consent and adequate pain relief, and improving access to contraception for menstrual healthcare in line with the committee’s recommendations.
It said: “The government agrees with the committee’s overarching findings and recommendations for improving women’s health outcomes and experiences.
“We acknowledge the impact that menstrual health conditions can have on women’s lives, relationships, and participation in education and the workforce.
“We recognise that more needs to be done to support women with menstrual health conditions, particularly around listening to women, improving information and education, and enhancing patient experience.”
However, there was no commitment to increase school nurse provision, no measurable actions and targets on countering online misinformation, no new commitments to end inappropriate censorship of women’s online health content, and no further initiatives on tackling racial discrimination or understanding the menstrual wellbeing needs of young disabled and Deaf women.
The response comes after analysis by The Times suggested the government is allocating 60 per cent more funding to its men’s health strategy than to its renewed strategy for women’s health.
Sarah Owen, chair of the Women and Equalities Committee and Labour MP, said: “WEC’s 2024 ‘medical misogyny’ report warned 18 months ago of women in unnecessary pain and undiagnosed for years and called on the Government to recognise the benefits of increased investment in early diagnosis and treatment.
“Our follow up report this March cautioned girls’ and women’s health are not being sufficiently prioritised in system-wide NHS reforms, while initiatives which have proven to be successful in reducing waiting lists and improving women’s healthcare access, such as women’s health hubs, risked being scaled back or discontinued.
“While it’s welcome to see a focus on tackling ‘medical misogyny’ in April’s renewed Women’s Health Strategy and an emphasis on women’s voices being heard, this must be backed by adequate funding, not financial half measures, particularly when compared to men’s health.
“Significant questions remain following today’s response publication over the adequacy of investment being provided, including for workforce training, menstrual health education in schools, research and additional ring-fenced funding for women’s health hubs to deliver services within the emerging neighbourhood health framework.
“There are both opportunities and risks when it comes to increasing use of technology in women’s healthcare.
“As the Committee’s report set out, social media companies should be held to account for inappropriate and disgraceful ‘shadow banning’ censorship of important women’s health content and there should be a rigorous approach to tackling the risks from ineffective, unsafe and exploitative for-profit FemTech apps.
“The Government should take the problem of ‘shadow banning’ more seriously.
“A strategy which does not fully address the concerns set out in WEC’s report, alongside measurable actions and timescales, will only scratch the surface of the issues facing women’s health.
“WEC will keep a close eye on progress and continue to push for long overdue tangible change for women and girls.”
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