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Male Birth Control Pill Passes Safety Trial in US
Male Birth Control Pill Passes Safety Trial in US

Man of Many

time2 days ago

  • Health
  • Man of Many

Male Birth Control Pill Passes Safety Trial in US

By Ben McKimm - News Published: 29 Jul 2025 Share Copy Link 0 Readtime: 3 min Every product is carefully selected by our editors and experts. If you buy from a link, we may earn a commission. Learn more. For more information on how we test products, click here. YCT‑529 male pill passes U.S. safety trial, no major side effects reported Non‑hormonal drug blocks vitamin‑A receptor, stopping sperm production initiation Study doses up to 180 mg showed unchanged hormones, mood, heart rate Requires three months of daily use to start or restore fertility Other male contraceptives coming: NES/T gel, ADAM reversible vas‑block implant Lads, the time has come. There's a male birth control pill on its way, and if we ask the ladies in the room, it's about damn time. It's been a great run for the rubber industry, and the vasectomy boys need a shoutout, too, but the ladies in our lives have been holding it down for too long with hormonal birth control pills and painful IUDs. It's our turn to carry some of the birth control burden, and with the new pill passing a safety trial in the US, it's just around the corner. Created by YourChoice Therapeutics, a single ascending dose study showed that up to 180mg of YCT-529 had no effects on heart rate, hormone (follicle-stimulating hormone, luteinizing hormone, and testosterone), sex hormone-binding globulin or inflammatory biomarker levels, sexual desire or mood, which is a substantial requirement in contraceptive development. We don't know how effective the pill will be at reducing sperm yet, but when you consider nearly half of all pregnancies worldwide are unintended, that information couldn't come sooner. Image: Unsplash The first non-hormonal oral contraceptive for men, YCT-529, blocks a vitamin A metabolite from binding to its receptor in the testes, preventing the chain of gene-expression changes required to start the sperm-making process. Sounds complicated, but Stephanie Page, an endocrinologist at the University of Washington School of Medicine, who wasn't involved in the study and spoke to says, 'We really need more reversible contraceptive methods for men.' However, Page doesn't go quite so far as to say that the large claim of no side-effects on a small 16-person human trial should be taken so literally. 'I think it would be overstating the data to say they know much about side effects yet,' she told the website. 'Every medication on the market has side effects.' It takes three months for the body to produce mature sperm cells. That means the pills would take three months to become effective, and three months to resume normal sperm production. YCT-529 is not the only reversible male birth control method being developed. There's a gel called NES/T in the clinical trial pipeline in the US, which is applied daily to the shoulders and upper arms before being absorbed into the bloodstream through the skin. There's also a hydrogel implant called ADAM, which acts as a reversible vasectomy by blocking the vas deferens.

Breakthrough In Male Birth Control As Hormone-Free Pill Passes Human Safety Test
Breakthrough In Male Birth Control As Hormone-Free Pill Passes Human Safety Test

NDTV

time23-07-2025

  • Health
  • NDTV

Breakthrough In Male Birth Control As Hormone-Free Pill Passes Human Safety Test

Researchers have been working on experimental hormone-free male birth control pills, with its first safety test in humans just passed in a breakthrough. The latest results from the early phase 1 clinical trial were published on Tuesday in Communications Medicine. The daily pill, called YCT-529, works by blocking a vitamin A metabolite from binding to its receptor in the testes. It prevents sperm production without affecting hormone levels, the study revealed. The phase 1 clinical trial was conducted on 16 healthy men who had undergone vasectomies. The results showed that the drug was well-tolerated with no serious adverse events reported. The optimal dosage is expected to be around 180 mg, based on the trial results. However, further studies will determine the exact dosage. The trial did not assess the pill's efficacy in reducing sperm and preventing pregnancy, with the medicine developer, YourChoice Therapeutics, running trials to collect that data. However, Dr Stephanie Page, an endocrinologist at the University of Washington School of Medicine, who wasn't involved in the study, said that the safety finding is a crucial milestone. "We really need more reversible contraceptive methods for men," Page said as quoted by Scientific American. Animal studies have shown that fertility returns within 4-6 weeks after stopping the drug in mice and 10-15 weeks in non-human primates. The pill would provide a safe, reversible and non-hormonal alternative to current male birth control methods, such as condoms and vasectomies. "A safe and effective male pill will provide more options to couples for birth control," Gunda Georg, who is a professor in the University of Minnesota College of Pharmacy, said in a statement. The drug molecule was developed there. "It will allow a more equitable sharing of responsibility for family planning and provide reproductive autonomy for men." The pill is currently in phase 2 clinical trials. It may take several years to become available on the market, if it gets approval. Other options in development include NES/T, a hormonal gel, and ADAM, a hydrogel implant that acts as a reversible vasectomy. "The positive results from this first clinical trial laid the groundwork for a second trial, where men receive YCT-529 for 28 days and 90 days, to study safety and changes in sperm parameters," the study authors wrote in their paper.

Breakthrough for MALE birth control pill: Experimental hormone–free tablet passes its first safety test in men
Breakthrough for MALE birth control pill: Experimental hormone–free tablet passes its first safety test in men

Daily Mail​

time23-07-2025

  • Health
  • Daily Mail​

Breakthrough for MALE birth control pill: Experimental hormone–free tablet passes its first safety test in men

For decades, the responsibility of taking a birth control pill has been placed firmly on the shoulders of women. But that could soon change – as an experimental pill for men that works by blocking sperm production has just passed its first safety test in humans. The hormone–free contraceptive tablet, called YCT–529, has already been found to prevent 99 per cent of pregnancies during experiments in mice. It works by blocking access to vitamin A in the testes, preventing sperm production without affecting testosterone levels – meaning libido is not impacted. The male pill, which experts hope will be available this decade, is the only one currently being tested in humans. For the latest trial, researchers recruited 16 men who were put on different doses of the pill across several days. Instead of testing how effective it was in humans – all of the men had undergone vasectomies – the aim was to discover if there were any side–effects. Analysis revealed there were no concerning changes in heart rate, hormone function, inflammation, mood or sexual function. Next, the team will test the pill in larger trials that will look at how effective it is in preventing sperm production in humans. The results of the safety trial, published in the journal Communications Medicine, are a critical first step toward getting the pill approved, experts said. 'We really need more reversible contraceptive methods for men,' Dr Stephanie Page, an endocrinologist at the University of Washington School of Medicine and who wasn't involved in the study, told Scientific American. Currently, the other male birth control options are vasectomies – a surgical procedure that involves cutting and sealing the tubes that carry sperm from the testicles – or condoms. Vasectomies, also known as 'the snip', can be reversed but the success rate of reversal procedures vary widely. Earlier tests in male primates also found the drug lowered sperm counts within just two weeks. Crucially, both mice and non–human primates fully regained fertility after stopping the drug and no side effects were detected in either species. Mice regained fertility within six weeks, while non–human primates fully recovered their sperm count in 10 to 15 weeks. How does it work? Researchers have understood for decades that vitamin A is essential for male fertility. YCT–529 is a retinoic acid receptor–alpha (RAR–a) inhibitor that prevents production of sperm cells in the testes as well as their release. It does this by blocking RAR–alpha – one of three nuclear receptors that bind retinoic acid, a form of vitamin A. YCT–529 is being worked on as part of a collaboration between University of Minnesota College of Pharmacy, Columbia University in New York and San Francisco–based firm YourChoice Therapeutics. 'A safe and effective male pill will provide more options to couples for birth control,' Gunda Georg, chemist and pharmacist at the University of Minnesota, said earlier this year. 'It will allow a more equitable sharing of responsibility for family planning and provide reproductive autonomy for men.' Both the animal studies and the human trial results suggest that the approved pill would likely be taken once a day, but further trials will confirm that dosing. 'The positive results from this first clinical trial laid the groundwork for a second trial, where men receive YCT–529 for 28 days and 90 days, to study safety and changes in sperm parameters,' the study authors wrote in their paper, published in the journal Communications Medicine. Currently, around a quarter of women who use contraception take an oral birth control pill, but there are no equivalent methods available for men. If the male pill proves to be as effective in humans as it is in mice, it would be on a par with the female birth control medication. Lead author and YourChoice Therapeutics' Chief Science Officer Nadja Mannowetz said: 'A peer–reviewed publication for our first–in–human study reinforces YCT–529's strong safety profile. 'It also shows "the Pill for men" had no effect on sexual desire or mood.' Nearly half of all pregnancies globally are unintended, suggesting an urgent need for more male contraceptive options. There is also high demand for new methods. A recent study showed men are very interested in using new male contraceptive options and women are confident they'll take them correctly. 'Studies and surveys continue to show that men want to share the burden of pregnancy prevention with their partners,' Akash Bakshi, CEO of YourChoice Therapeutics, said. 'But they have just one non–permanent contraceptive option—condoms—and it's 170 years old. Innovation is long overdue. 'Data show men favour an oral contraceptive and one that's hormone–free, positioning YCT–529 as potentially transformative for a healthcare segment that's been stagnant for more than a century and a half.' Women have several birth control options available including short–term rapid methods like birth control pills and patches and a contraceptive cap or diaphragm. They also have long–term options such as implants, which produce hormones that stop the release of an egg. Some opt for an intrauterine device – a T–shaped device placed into the uterus to prevent an egg from implanting. The birth control pill or patches are about 93 per cent effective at preventing pregnancies. However long–term devices like the intrauterine device are more than 99 per cent effective. There have been few changes in male contraception compared with the range of options available to women. Although there's ongoing research into a male contraceptive pill, there is not one available yet. At the moment, the 2 contraceptive methods available to men are: Condoms – a barrier form of contraception that stops sperm from reaching and fertilizing an egg Vasectomy – a minor, usually permanent, surgical procedure that stops sperm from reaching the semen ejaculated from the penis The withdrawal method of taking your penis out of your partner's vagina before ejaculating is not a method of contraception. This is because sperm can be released before ejaculation and cause pregnancy.

First Hormone-Free Male Birth Control Pill Shown Safe in Early Human Trial
First Hormone-Free Male Birth Control Pill Shown Safe in Early Human Trial

Scientific American

time22-07-2025

  • Health
  • Scientific American

First Hormone-Free Male Birth Control Pill Shown Safe in Early Human Trial

When it comes to birth control, the market has long been skewed: female contraception comes in a variety of pills, implants, injections and devices, all approved by U.S. regulators. Condoms and vasectomies are the only male contraceptives available. Researchers have been chipping away at this problem for decades, and progress is finally ramping up. Now a male birth control pill with an entirely new kind of contraceptive mechanism has been tested for the first time in humans. In the first clinical trial of its kind, a nonhormonal oral contraceptive that reversibly stops sperm production has just been deemed safe for human use. The daily pill, called YCT-529, blocks a vitamin A metabolite from binding to its receptor in the testes; this prevents the chain of gene-expression changes that are required to start the sperm-making process. Safety results from the early phase 1 clinical trial were published on Tuesday in Communications Medicine. The trial did not assess the pill's efficacy in reducing sperm, and the drug's developer, YourChoice Therapeutics, is currently running trials to collect that data. But the safety finding is a crucial milestone, says Stephanie Page, an endocrinologist at the University of Washington School of Medicine, who wasn't involved in the study and has worked on other male hormonal contraceptives for more than 20 years. 'We really need more reversible contraceptive methods for men,' she says. On supporting science journalism If you're enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today. The small trial included 16 healthy men aged 32 to 59, all of whom had undergone a vasectomy—a common surgery to prevent the release of sperm by snipping the vas deferens ducts in the scrotum. Enrolling only such participants was an extra precaution to avoid the risk of permanently affecting participants' fertility; no one has clinically trialed a nonhormonal male contraceptive pill before, says Nadja Mannowetz, co-founder and chief science officer of YourChoice Therapeutics, who oversaw the new trial. Using nonfertile participants worked for the trial because the team wasn't yet evaluating the drug's effectiveness but rather its tolerability and bioavailability (active levels that build up in the body), Mannowetz says. Participants were split into two groups. In the first, people either received an initial dose of 10 milligrams (mg) of YCT-529 and then a second, 30-mg dose two weeks later or got a placebo each time. Participants in the second cohort either received a first dose of 90 mg and then a second dose of 180 mg two weeks later or always received a placebo. All participants took the pills after fasting. Four from each cohort were selected to return and take a third, 30-mg dose after a high-fat, high-calorie breakfast to see whether food might affect the drug's tolerability. Across dosages 'we saw good and quick bioavailability,' meaning the drug didn't rapidly break down in the body, Mannowetz says. On average, it took two to three days for the drug availability levels in the blood to reduce by half—a promising result that suggests the pill might only be needed once daily if it later proves effective at reducing sperm. Mannowetz anticipates the final dosage that will hit stores if the drug is eventually approved by the U.S. Food and Drug Administration will probably be closer to the higher amount tested, 180 mg, though follow-up trials will help discern the exact optimal dose. The research team didn't note any adverse side effects related to the drug. An advantage of a nonhormonal contraceptive medication is that, in theory, there's a smaller chance of certain side effects such as changes to sexual function, libido or mood, Mannowetz says. The results are exciting and important, Page says—but she points out that this was just one small trial. 'I think it would be overstating the data to say they know much about side effects yet,' she says. ' Every medication on the market has side effects.' Several other reversible male birth control methods are now in the clinical trial pipeline as well. The furthest along is NES/T, a combination of the progestin Nestorone and testosterone. Applied daily as a gel to the shoulders and upper arms, it is absorbed into the bloodstream through the skin. Like the YCT-529 pill, the gel targets sperm production, but it does so by circulating testosterone and progestin—hormones that tell the brain to halt the production process. Researchers have just completed a larger, longer phase 2 clinical trial of NES/T to show effectiveness and will hopefully start a phase 3 trial soon, says Page, who has been involved in the gel's clinical research. Users of a male contraceptive that targeted sperm production, such as NES/T or YCT-529, would need to take it for about three months daily before it would take effect because that's how long it takes the body to produce mature sperm cells. Sperm production would resume about three months after a user stopped taking the medication. A couple of other candidates for hormonally acting daily male contraceptive pills are in early development. A hydrogel implant called ADAM is also being tested in early clinical trials. ADAM acts as a reversible vasectomy, physically blocking off the vas deferens to prevent sperm release until the implant is removed. And studies show growing interest. One paper published in 2023 found that 75 percent of more than 2,000 men surveyed in the U.S. and Canada were willing to try novel contraceptives. And a report in 2019 found nearly 50 percent of U.S. men aged 18 to 49 who had sex with women, did not have a vascectomy or beliefs that prevented the use of contraception and did not wish to parent a pregnancy were 'very interested.' These stats line up with Page's experience in the field: 'Men are very eager to have more reproductive agency and to participate in contraception,' she says, and all these contraceptives in the pipeline could elevate individuals' and couples' agency over their sexual and reproductive lifestyles.

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