By Tiffany Chien

Graphic design by Stefanie Jinyin Wang

While pills, implants, intrauterine devices, and barrier methods have provided women with reproductive autonomy for decades, the current contraceptive landscape places a disproportionate amount of the physical and mental burden for pregnancy prevention on women.¹ But what about men? Beyond condoms, which has a failure rate of up to 16% with typical use², and vasectomies, with concerns over their semi-permanency, male contraceptive options remain limited, and progress has been slow.² 

The development of safe, efficacious male contraceptives has proven to be a significant challenge. Specifically, a male birth control pill would have to suppress sperm production and/or viability or, inhibit ejaculation in a way that would avoid adverse mood and sexual side effects. 

What types of male contraceptive candidates are in the pipeline? 

Promising research is being conducted for various hormonal and non-hormonal pharmaceuticals, and medical devices that could provide men with a diversity of contraceptive options. Birth control methods need to be dependable and, ideally, reversible; these methods should also have minimal side effects, be easy to take or use, and be affordable.³ 

One hormonal method that has been successful as a long-acting reversible method for men is the NES-T (Nesterone/Testosterone) gel.⁴ The gel is applied to each shoulder topically to prevent sperm production while maintaining testosterone at healthy levels to minimize side effects and sustain sexual function. This product is currently in phase 2b clinical trials to evaluate dosage and efficacy, and researchers are hopeful that it will be the first male contraceptive product to reach phase 3 (confirmation of safety and efficacy in a larger cohort) and hopefully become readily available within the next five to six years.⁴ 

While hormonal methods will likely be first to hit the market, alternative, non-hormonal options are still needed. In addition to having fewer side effects, non-hormonal contraceptives provide the potential for more diverse drug profiles compared to hormonal counterparts that are limited to early-stage sperm inhibition.⁵ There are several reversible non-hormonal pills currently in clinical trials. YCT-529 is a retinoic-acid receptor alpha inhibitor that works by blocking vitamin A access in the testes, thereby inhibiting sperm production.⁶ Additionally, a fast-acting, short-term male birth control pill using a soluble adenylyl cyclase (sAc) inhibitor, which has been shown to slow sperm motility and prevent sperm maturation in mice⁷, is currently in preclinical testing, with plans to initiate clinical trials sometime in 2025 for market release by 2031 if shown to be effective in humans.⁸

The last category of male birth control involves medical devices. In contrast to pharmaceutical methods, which on average have a research and development period of 12 years, medical devices benefit from a shorter timeline—approximately seven years to regulatory approval.⁹ These devices are typically referred to as vas-occlusive contraception, as they involve implanting a device or material (i.e. hydrogel) that blocks the transport of sperm through the vas deferens, the tube that carries sperm to the ejaculatory ducts.¹⁰ Unlike a vasectomy, which doesn’t always guarantee reversibility, vas-occlusive methods are easily reversible through the natural degradation of the material, allowing users to restore their fertility if desired.¹⁰ One company developing occlusion gel contraceptives is Contraline, with its product ADAM, which is in phase 1 safety trials.¹⁰

Why has the production of male contraceptives taken so long? 

Beyond scientific challenges, there are significant financial, regulatory, and cultural barriers to the use of male contraceptives. Once the drugs have been shown to be effective, there remains several safety requirements that must be met to ensure the side effects are minimal. Part of the drug approval process requires assessing the risk and benefits to the individual taking the drug¹¹. Unfortunately, for male contraceptives, the risk-benefit criteria are higher than female contraceptives. For men, birth control offers no direct health benefits, so these medications must meet exceptionally high levels of safety—with no risks and side effects—to receive approval. In contrast, female birth control typically causes a range of side effects, including irregular bleeding, mood changes, weight gain, headaches, and nausea.¹² However, these risks are generally deemed acceptable by the Food and Drug Administration, given that the potential morbidity and mortality of pregnancy and childbirth far exceed those associated with contraceptive use.

In our interview with Dr. Stephanie Page, endocrinologist and a professor of medicine at University of Washington, she is hopeful that the regulatory approval criteria for male contraceptives will evolve because “we should be thinking about the risk as a [couple], not just the man, since both [parties] are responsible for the pregnancy, and both should be responsible for the outcome of the pregnancy […] because we’re trying to prevent a health consequence in the partnership.”

Bringing male contraceptives to market requires substantial investments, beyond grants available through government funding. Unfortunately, pharmaceutical companies that could provide funding for male contraceptives do not perceive a demand for these medications. Moreover, recent federal funding cuts by the Trump administration to reproductive health research terminated many studies previously funded by the United States Agency for International Development (USAID)¹³, including a study on female sAC-based contraceptive. 

Another key challenge lies in cultural barriers to male contraceptive uptake. Despite the growing interest in male contraceptives, many couples may still rely on female contraceptives due to the lack of awareness of, and education about, the alternative options for men. That doesn’t mean couples are satisfied with female contraceptives, especially since these existing methods have been associated with several adverse side effects.¹⁴

Experts believe that a shift in mindset would promote the uptake of male contraceptives. In our conversation with Dr. Logan Nickels, Chief Research Officer at Male Contraceptive Initiative, he emphasized that “the conversation has to shift away from thinking about male and female contraceptives as mutually exclusive landscapes with two separate populations demanding them… male contraception [is] women’s health.” The advancement of male contraceptives will more equitably distribute the benefits and burdens of pregnancy prevention, promoting a sense of shared responsibility for all involved. 

Acknowledgements: 

To learn more about the current science behind male contraception, check out episode #128 of Raw Talk Podcast, “Male Contraceptives: A Shared Responsibility”. We would like to acknowledge the efforts and ideas of the episode #128 team: Braeden and Hannah were Show Hosts; Mariam and Kristina were our Content Creator and Promo respectively; Angela was our Audio Engineer; and Atefeh was our Executive Producer.

References

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