Efforts to develop effective male contraceptives have been gaining momentum with promising new developments. The quest for a viable solution has been ongoing since the discovery of gossypol in the 1970s, which worked too well, causing sterility in 10% of men, even after discontinuation. Despite the challenges, two companies, Contraline and NEXT Life Sciences, are making strides with occlusion gels currently in development. These advances come amidst growing concerns about male contraception in several U.S. states where access to women's services is increasingly uncertain.
The U.S. Food and Drug Administration (FDA) has yet to approve any male contraceptive. This has prompted innovation in medical devices, such as Plan A and ADAM, which benefit from a faster regulatory approval process than pharmaceuticals like NES/T. Brian Nguyen, a gynecologist at the University of Southern California's Keck School of Medicine, emphasizes the importance of developing multiple methods to meet diverse user needs.
Jesse Mills, director of UCLA's Men's Clinic, highlights the urgent need for male contraceptive options in various U.S. states. A trial over 60 years ago demonstrated the safety and efficacy of a compound inhibiting retinoic acid, crucial for sperm production. The success of NES/T depends on the next testing phase, should it proceed. Preliminary data from 12-month NES/T testing showed no adverse effects and no unintended pregnancies among 25 participants.
The hydrogel used in ADAM acts locally in the vas deferens and is inert, ensuring reversibility with a subsequent injection that dissolves the gel. A recent study published in Science in 2024 discovered that a molecule blocking STK33 function can induce temporary infertility in mice. A sAC inhibitor for men might receive regulatory approval within a decade if clinical trials progress smoothly.
The vision for male contraception includes on-demand solutions where men could take a pill and achieve temporary infertility within half an hour. NES/T requires four to twelve weeks of daily application to reduce sperm count to below one million per milliliter, effectively preventing pregnancy. Normal sperm production resumes within six months after stopping NES/T.
John Amory points out that concerns about side effects are a significant barrier to male contraceptive development. He emphasizes the importance of adherence to ensure effectiveness.
"Concerns around side effects are partly what’s causing holdups in male contraceptive development," said John Amory.
"Adherence is critical — if men don’t use it every day, it won’t work," he added.
Oscar Ahlqvist shares the personal impact of his girlfriend's struggle with female birth control side effects.
"My girlfriend Kerstin doesn’t handle birth control well and has bad side effects," Oscar Ahlqvist noted.
Steve Kretschmer underscores the stringent requirements for drug approvals, emphasizing the necessity for minimal side effects.
"There’s no drug that will be approved unless it has a perfect side effect profile," stated Steve Kretschmer.
Despite these challenges, Diana Blithe remains optimistic about NES/T's prospects, citing positive trial outcomes.
"Effectiveness is good. Reversibility is really good — we can be very reassuring about returning fertility [after stopping treatment]. We don’t see any problems," Diana Blithe affirms.
Alexandra Joice Berger acknowledges the limited scale of current trials but remains hopeful about NES/T's safety and reversibility.
"It’s a very small trial, but it seems 100 percent reversible and safe," Alexandra Joice Berger remarked.
Steve Kretschmer questions the perceived health benefits of male contraceptives, which may affect their adoption.
"There’s no [health] benefit for them. Zero," Steve Kretschmer commented.
Diana Blithe highlights the lengthy process required for developing male contraceptives.
"It takes a long time to do this," she observed.
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