Revolutionary Male Contraceptive Gel Finally Unveiled

Medical News: A new male contraceptive gel, combining two hormones, has demonstrated significantly faster suppression of sperm production compared to previous methods. This development marks a significant step forward in male contraception. This breakthrough could offer men a reliable, effective, and reversible contraceptive option, addressing a long-standing gap in reproductive health.


Revolutionary Male Contraceptive Gel Finally Unveiled
 
Study Overview and Key Findings
The study, funded by the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, involved 222 men aged 18 to 50. These participants completed at least three weeks of daily treatment with the contraceptive gel, which consists of 8 milligrams (mg) of segesterone acetate and 74 mg of testosterone. The gel is applied once daily to each shoulder blade.

Researchers defined effective contraception as a sperm count of one million or fewer per milliliter of semen. By week 15, 86% of participants achieved this level of suppression, with a median suppression time of less than eight weeks. This is a significant improvement over prior methods, where hormonal contraceptives given by injection took between nine and 15 weeks to achieve similar results. The combination of segesterone acetate and testosterone not only accelerated sperm suppression but also allowed for a lower dose of testosterone, maintaining normal sexual function and other androgen-dependent activities.
 
The Need for Male Contraception
Senior researcher Diana Blithe, Ph.D., who leads the Contraceptive Development Program at the National Institutes of Health (NIH), emphasized the importance of this development. She told various Medical News media, "The development of a safe, highly effective, and reliably reversible contraceptive method for men is an unmet need.” Historically, hormonal agents have shown potential, but their slow onset in suppressing sperm production has been a significant drawback.
 
The trial's promising results come at a time when demand for male contraceptive options is growing. According to recent surveys, a significant number of men are willing to use new contraceptive methods. In 2019, the nonprofit Male Contraceptive Initiative estimated that more than 17 million men in the U.S. wanted more birth control options. This interest has only increased since the Supreme Court overturned Roe v. Wade in 2022, highlighting the need for diverse and effective contraceptive solutions.
 
Broader Implications and Future Prospects
The rapid suppression of sperm production is a key advantage of this new gel, potentially increasing its appeal to users. The ongoing phase 2b trial will continue to assess the gel's effectiveness, safety, acceptability, and the reversibility of contraception after treatment stops. Testosterone treatment alone decreases sperm production, with a median time of 15 weeks. However, the combination of segesterone acetate speeds up the suppression time and reduces the necessary dose of testosterone. In the daily seg esterone-testosterone gel regimen, blood levels of testosterone are kept in the physiological range, ensuring the maintenance of normal sexual function and other androgen-dependent activities.
 
Nonhormonal Alternatives in Development
In addition to the hormonal gel, other nonhormonal male contraceptive methods are also in development. YourChoice Therapeutics has been testing a nonhormonal pill, YCT-529, which works by blocking the vitamin A receptor important for male fertility. Initial trials in the U.K. have shown the pill to be safe and free of side effects, with plans for larger trials underway.
 
Similarly, Contraline, a medical device company based in Charlottesville, Virginia, is developing a nonhormonal male birth control method involving the injection of a gel called ADAM into the vas deferens. This single 15-minute procedure is designed to block sperm transport for years, functioning similarly to an intrauterine device (IUD) for women. Early clinical trials in Australia have shown promising results, with a 99.8% to 100% reduction in the number of motile sperm within 30 days of the procedure.
 
Challenges and Financial Hurdles
Despite these advancements, the path to market for male contraceptives is fraught with challenges, primarily financial. Developing new drugs and bringing them through the regulatory approval process requires substantial investment. The Congressional Budget Office estimates that it can cost between $1 billion and $2 billion to take a drug through clinical trials and onto the market.

The Male Contraceptive Initiative, the second-largest funder of male contraceptive research after the NIH, grants about $1.5 million annually. This amount is insufficient to fund large-scale, advanced human trials necessary for FDA approval. Most academic researchers or small biotech companies developing new drugs rely on partnerships with major pharmaceutical companies to fund these trials. However, without substantial financial backing, even promising developments like the hormonal gel may struggle to progress.
 
Conclusion: A New Era in Male Contraception
The development of this new male contraceptive gel represents a significant advancement in reproductive health. With its rapid onset of sperm suppression and maintenance of normal sexual function, it offers a promising option for men seeking reliable and reversible birth control. As research continues, the potential for this gel to become a widely accepted contraceptive method grows, offering men greater control over their reproductive health and contributing to a more balanced approach to contraception.
 
Future innovations in male contraception, including both hormonal and nonhormonal methods, hold the promise of expanding the range of options available, addressing a significant unmet need, and potentially transforming the landscape of reproductive health.
 
The clinical trial results of the new hormonal contraceptive gel were presented at the recent Endocrine Society's annual meeting, ENDO 2024, in Boston.
https://www.endocrine.org/news-and-advocacy/news-room/2024/endo-2024-press-blithe
 
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