A tipping point for birth control: As barriers rise, is contraceptive innovation at risk?

The story of modern contraception is one of widespread use, but limited innovation. More than 90% of American women aged 15-49 have employed at least one form of birth control in their lives, whether to prevent pregnancy or address other medical needs.

Despite the revolutionary impact of the original birth control pill, and the decades of medical innovation seen since, today's contraceptive landscape remains strikingly similar to what was available in the late 20th Century. In fact, many women currently rely on the exact same options their mothers and grandmothers once used.

While demand for broader contraception options is clear, getting new products to patients is a complicated process. And with a new administration taking aim at diversity programmes, reproductive information, and research funding, questions remain over the future of contraceptive research – and access – in the US. 

While contraceptive research for women faces mounting challenges, male contraceptive methods – long overlooked – are beginning to gain traction. With promising developments in hormonal treatments and increasing engagement from trial participants, researchers are asking whether this could be a turning point. Could the barriers to progress in female contraception be inadvertently accelerating innovation in male birth control?

The stalled evolution of women's contraceptives

Contraception comes in many forms, yet, the variety available today has barely changed in decades. The combined pill – developed over 60 years ago – remains one of the most prescribed options, despite known risks like increased clotting, nausea, and mood swings. Progestin-only pills and injectables offer alternatives, but many users still experience side effects that make long-term use difficult. Meanwhile, long-acting reversible contraceptives, such as implants and hormonal IUDs, provide extended protection, but they require clinical procedures and can cause irregular bleeding.

For those seeking hormone-free options, choices are limited. The copper IUD, which prevents pregnancy without altering hormone levels, is effective, but can lead to painful cramping and prolonged bleeding. Barrier methods, including condoms and diaphragms, require consistent use, which reduces their reliability. The growing popularity of period-tracking apps has introduced a non-invasive, technology-driven approach, yet, these apps rely on highly regular cycles and may not be suitable for those with irregular periods.

Beyond personal choice, systemic factors further complicate contraceptive access. The FDA's milestone approval of Perrigo's contraceptive pill, Opill, in 2023 opened a pathway for over-the counter contraceptive pills in the US, in what the company's stated would empower millions "to enter a new era of reproductive health access in the United States." While this development removed the unnecessary barrier of obtaining a prescription, it was two-decades in the making. 

While the success of Opill was a big step forward for affordable birth control access, with rates of permanent sterilisation procedures rising in the wake of abortion restrictions, women are left with an uncertain future – continue relying on decades-old contraceptive methods, wait another 20 years for the next breakthrough, or consider irreversible options. If research stalls, the prospect of better, safer, and more personalised contraception may remain out of reach.

The Dobbs effect

Although the 2022 Dobbs vs Jackson Women's Health decision to overturn abortion protections established by the landmark Roe vs Wade ruling never explicitly mentioned clinical trials or contraceptive research, its impact extends far beyond abortion access, creating unprecedented challenges for medical research. 

As abortion bans spread across numerous states, pharmaceutical companies and research institutions confront complex legal and ethical dilemmas that fundamentally alter how clinical research involving women is conducted.

"Dobbs isn't just about abortion – it's about fundamental access to reproductive healthcare, and that includes clinical trials," explains Allison Whelan, assistant professor at Georgia State University College of Law. "When research sponsors see legal uncertainty, they hesitate to include women in trials altogether."

This hesitation stems from practical concerns about trial participation. "Clinical trial protocols often require termination of pregnancy for continued participation. With abortion now illegal in Texas, participants there simply cannot remain in studies if they become pregnant," Whelan notes.

The implications extend beyond access issues. Many states have enacted laws recognising foetal personhood, creating additional legal risks. "There is certainly a concern not only from the sponsor putting the women in the trial for being potentially charged with harm to a foetus, but the women and the pregnant person or potentially pregnant person. Investigational or not, every single drug has risk," Whelan explains. "Although state abortion laws do not explicitly allow the criminalisation of the pregnant person for getting an abortion, pregnant people have been prosecuted for harm of the foetus or death of the foetus for their actions during pregnancy. And those prosecutions have increased after Dobbs." 

The situation is further complicated by shifting federal policies. While the FDA introduced Diversity Action Plans in 2024 to increase the representation of women in clinical studies, these initiatives have since been abandoned.

"At the time Dobbs was decided, there was still a huge initiative within the FDA to increase diversity in clinical trials. Now we have these colliding forces – with the Trump administration entering the White House, we're seeing pushback against even terminology that implicates diversity," says Whelan.

The consequences are already visible across the research landscape. "What we're seeing is an exodus of reproductive health research from states with strict abortion laws," Whelan observes. "The long-term effects of this shift on clinical trials will be profound."

The regulatory uncertainty creates a troubling paradox: "If a woman in a clinical trial becomes pregnant, she may have no option but to drop out. That's a significant disruption to research that requires long-term participation."

This places women in an impossible situation: "Participate in research with no clear protections, or simply be excluded from the development of treatments they'll ultimately rely on. In some states, even mentioning the word 'pregnancy' in a research proposal raises red flags. That's how extreme the chilling effect has become."

A turning point for male birth control?

For decades, men's role in contraception has remained largely unchanged, limited to condoms, withdrawal, or permanent surgical options. However, the tide may be shifting. While innovation in female contraception faces new challenges, hormonal male birth control research is gaining momentum. With fewer barriers to trial recruitment and a shifting regulatory landscape, promising developments are emerging after decades of limited progress.

Diana Blithe, PhD, chief of the contraceptive development programme at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, explains why a male pill has remained elusive: "You might ask why there is no pill – because replacement testosterone is cleared so rapidly, you would have to take multiple doses a day. And despite many years of attempts, a longer-acting version has not been developed without causing some side effect in the liver, which we don't want."

The science behind male contraception requires careful hormone balance. "Normal production of sperm requires very high local testosterone levels in the testes," Blithe explains. When using progestin hormone (Nestorone), it "inhibits production of pituitary LH that is responsible for testosterone production in the testes. Without LH, testosterone is not made in the testes and sperm production stops." The challenge lies in maintaining the right balance: "You have to replace that testosterone in the blood at a level where you're maintaining normal sexual function, so it's normal testosterone levels in the blood, but it doesn't re-accumulate in the testes in a high enough amount to restart sperm production."

Recent trials have shown promising results with an innovative delivery method. "We concentrated the two hormones into a very small amount of gel, which is dispensed from a metered dose pump – you pump a dose into your palm, apply it on one shoulder, pump another dose for the other shoulder, and then you're done for the day."

Blithe challenges the common misconception that men aren't interested in contraception: 

"The idea that men won't take it is based on an assumption, not fact. Some men won't. But, from what we've seen, there are a lot of men who really want to be able to do this, and there are a lot of couples who would love to have this in their arsenal of options."

The pharmaceutical industry, initially hesitant, is showing increased interest. "They were not real anxious to join us at the very early stages 20 years ago, but now we have a lot of proof of concept and positivity in terms of responses. Once we break through and they see that there is a market, that will bring a lot more interest into the field."

Participant feedback has been overwhelmingly positive. "My favourite comment from the men who participated is 'Can I re-enrol?'" Blithe shares. "From the time you enrol, it takes about 20 to 24 months to complete the study – from achieving suppression, through efficacy testing, to full recovery – which really underscores the long-term commitment required."

Perhaps most significantly, Blithe emphasises that male contraception fundamentally benefits women: "My favourite comment from the women who participated was, 'I can't believe how wonderful this was to not be on my method, which didn't work well for me.' So it meant a huge amount to them to be in the study, and I think that's probably the most powerful message to try to get out there: that this is a Women's Health issue."

Where do we go from here?

Contraceptive choices have long been shaped by a complex interplay of science, policy, and societal attitudes. Today, those forces are colliding in new and unpredictable ways. As women face growing barriers to clinical research participation, and male contraceptive innovation gains momentum, the future of reproductive health remains uncertain.

What happens next will depend on whether research institutions and policymakers recognise the urgency of preserving access and funding for women's reproductive health. The advancement of male contraception is a long-overdue step forward, but it cannot come at the cost of limiting research into better, safer, and more accessible options for women.

Will the next generation face even fewer options than those before them? Or will this moment serve as a wake-up call for policymakers, funders, and the pharmaceutical industry to rethink their approach to contraception and clinical research?

Eloise McLennan

About the author

Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK.

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