MedCity Influencers

The Future of Birth Control: No Hormones, More Options for Men

The advancement, adoption of, and access to these options – regardless of age, geography, and financial considerations – requires the support of the scientific community, drug developers, funders, regulatory agencies, insurers, and lawmakers to make the concept of a hormone-free future a reality.

Women’s reproductive rights in the U.S. are narrowing. Meanwhile, 46% of all pregnancies in the U.S. are unintended, pointing to the stark evidence of the enduring need for access to effective, acceptable contraceptive options. Pregnancy termination is rarely a desirable option. However, its growing scarcity demands that we continue to explore new approaches to a problem that’s as old as humanity. In a country of abundance, we’re in a unique position to rethink and innovate contraceptives.  

Birth control: A long history of the same thing

Marking one of the most socially significant healthcare advances of the 20th century, the female birth control pill — commonly known as The Pill — debuted in 1960, and radically improved women’s social, economic, financial, and reproductive autonomy. Today, 64 years later, women can buy Opill, the first over-the-counter birth control pill, without a prescription. Despite the wait, this tremendous step forward marks a historic moment in contraceptive access. However, we seem to have set a low bar for innovation in birth control. Except for the copper IUD and barrier methods, modern female contraceptive options remain hormonal-based. Patches, injectables, implants and vaginal rings release smaller amounts of hormones, but 65 years have given women nothing but more of the same. The next monumental advance will be a birth control pill for men. But we can’t wait another 65 years. 

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A perfect storm that demands access and innovation 

With one of the highest rates of unintended pregnancy among affluent nations, access to effective birth control in the U.S. remains a critical need. The Affordable Care Act was a monumental step toward making it easier to access birth control by mandating insurance coverage. However, too many women — particularly the young and poor — still struggle to obtain reliable, effective birth control. This pervasive problem needs continued, focused attention and we can invest in innovation. In fact, powerful forces demand it. 

For decades, women have endured the burdensome side-effects of hormones. In fact, women began reporting side effects of The Pill soon after their clinicians wrote the first prescription. Today, social media has given younger women a voice, and they’re sharing their stories of side effects. Many are abandoning hormonal birth control for less effective contraceptive strategies: the latest data show 18-50% quit The Pill for hormone-free options like the rhythm method. This is making many nervous, and appropriately so. While women favor hormone-free — albeit less effective — birth control, access to pregnancy termination options is increasingly limited. Following Roe v. Wade’s dissolution, several states have enacted restrictive laws that limit women’s access to both contraceptives and pregnancy termination options.

While this is taking place, an interesting cultural shift is under way: men willing to use a hypothetical contraceptive method varies from as low as 13.6% to as high as 83.0%. New generations of men don’t view contraception as “a woman’s job.” They want to share responsibility, but their options are limited to condoms and vasectomy, which have significant limitations. Condoms have a failure rate of 13 percent. Vasectomy is an option but it’s a surgical procedure with no guarantee of reversibility, making it impractical for teenage boys and men who desire children. 

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It’s a perfect storm begging for a solution. One approach: we need more male birth control options. However, we want men to take them. For this reason, they must be hormone-free and easy to use.

A male birth control pill — 70 years in the making

The development of the first male contraceptive pill started in the 1950s in parallel with the female pill. However, researchers realized the drug candidate would require men to abstain from alcohol, and the trial ended. Male contraceptive development then turned to hormone-based approaches. Testosterone, the main male sex hormone, is key for sperm production. Impairing the levels of testosterone and/or associated hormones seemed like an elegant way to stop sperm production. In the 1990s, the World Health Organization (WHO) funded and conducted a multinational study with 271 men that established the effective reduction of sperm production by weekly intramuscular injections with enanthate, a form of testosterone. However, WHO abruptly ended the study because of hormonal side effects. After this somewhat spectacular failure, big pharma seemed to lose its appetite for investing in male contraceptive development programs. 

Currently, only the National Institutes of Health and the Population Council — both nonprofit organizations — are conducting several male hormonal contraceptive clinical trials: the furthest along is the transdermal Nestorone/testosterone combination gel that men apply daily onto their shoulders. 

Aspiring toward a hormone-free future

Contraception is in dire need of innovation. The side effects of hormonal-based birth control are repelling young women and have stymied the introduction of new male methods. This begs the need for hormone-free options beyond vasectomy and condoms. Hormone-free birth control options could give men a more acceptable, effective, and tolerable way to participate in pregnancy prevention. This would transform society in many ways. Importantly, it would reduce the hormonal burden for women. It could also reduce the number of unplanned pregnancies and the associated psychological, physical, emotional, financial and health burdens during this period of narrowing reproductive freedoms.

There are currently two non-hormonal male contraceptive methods in clinical development: a device and a therapy. The device acts as a reversible vasectomy: a clinician injects a biocompatible hydrogel into the vas deferens to block sperm. It is the first vas-occlusive product designed to be inert, non-permanent, and reversible. The therapy in development is a hormone-free male birth control pill (YCT-529), which I’m advancing as chief science officer for YourChoice Therapeutics. YCT-529 is a small molecule that inhibits binding of retinoic acid, a form of vitamin A, to its receptor in the testis, thereby preventing sperm production and sperm release.

Many have asked: “can we trust men to take a pill.” Combining either of these methods with at-home sperm count tests would give men control over their (in)fertility and help establish trust with a partner. 

Hormone-free birth control options for men would support true reproductive autonomy and equality. The significance for men and women could match the social, economic, and financial significance of the female pill. No doubt, it will change the way men and women approach birth control. Pregnancy prevention will no longer be “a woman’s job.” However, the advancement, adoption of, and access to these options – regardless of age, geography, and financial considerations – requires the support of the scientific community, drug developers, funders, regulatory agencies, insurers, and lawmakers to make the concept of a hormone-free future a reality. We cannot wait another 60+ years for the next innovation in birth control to happen.

Photo: mikdam, Getty Images

Nadja Mannowetz, PhD, is a sperm biologist advancing the first hormone-free birth control pill for men. She is a co-founder of YourChoice Therapeutics, Inc. and serves as its chief science officer.

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