New daily contraceptive for men could end era of women bearing family planning burden
The pill represents a significant breakthrough in male contraceptive options, which have remained limited to condoms and vasectomy for decades.
A ground-breaking non-hormonal contraceptive pill for men has successfully passed its first human safety trial, offering hope for a revolutionary shift in family planning responsibilities.
The daily pill, dubbed YCT-529, has been found safe for human use with no adverse side effects in the first clinical trial of its kind, according to a peer-reviewed study published in the prestigious scientific journal Nature.
For Boniface Njuguna, a trader in Thika, the news couldn't come soon enough. His partner struggles with contraceptive coils, finding them uncomfortable and problematic. Now, for the first time, he might have the chance to take control of their family planning himself.
"This is actually good news because my woman has issues with things like coils and reacts to them badly. It makes her so uncomfortable, so the fact that I can play a part in making our sex life healthier by taking a pill is very good," Njuguna told Nation.
Developed by YourChoice Therapeutics and trialled at Quotient Sciences' Phase 1 unit in Nottingham, the pill represents a significant breakthrough in male contraceptive options, which have remained limited to condoms and vasectomy for decades.
The findings mark a crucial milestone in the long-sought quest for effective male birth control. Previous attempts have faced significant setbacks, most notably a World Health Organisation trial in 2016 involving a two-hormone injection that showed 96 per cent effectiveness in preventing pregnancy but was halted due to severe side effects identified by an independent review panel.
"This is the first time anyone has clinically trialled a non-hormonal male contraceptive pill," explained Nadja Mannowetz, co-founder and chief science officer at YourChoice Therapeutics and the study's lead author.
The key advantage of YCT-529 lies in its non-hormonal approach. Unlike traditional hormonal contraceptives, this method theoretically reduces the risk of side effects such as changes to sexual function, libido, or mood that have plagued previous male contraceptive developments.
Stopping sperm production
The pill works by temporarily and reversibly stopping sperm production, allowing men to regain normal fertility after discontinuing use. This differs significantly from existing hormonal birth control methods, which rely on hormones such as oestrogen and progesterone to prevent pregnancy.
Current non-hormonal birth control options include barrier methods such as condoms, cervical caps, diaphragms, copper intrauterine devices (IUDs), spermicide, and natural family planning. Hormonal options range from combination pills containing both oestrogen and progestin to progestin-only pills.
In Kenya, popular hormonal contraceptives include combined pills such as Marvelon, Microgynon, and Mercilon, alongside progestogen-only options like Cerazette and emergency contraception such as Postinor 2.
The research addresses a pressing global issue, with scientists noting that nearly half of all pregnancies worldwide are unintended, demonstrating a clear need for additional contraceptive options.
"Even though men state that contraception should be a shared responsibility, their options are limited to condoms, which have a 13 per cent failure rate, and vasectomy, which is a surgical procedure with uncertain reversibility," the researchers explained. "This demonstrates the lack of highly effective and reversible options."
The prospect of male contraceptive pills has generated varied responses from potential users, with some expressing reservations about potential side effects.
Mr Joram Ateya, a communications consultant based in Nairobi, voiced his concerns: "We are being told that it is safe and non-hormonal, but what if I end up with side effects like weight gain, acne, mood changes, and changes in libido, then cease to function as a man?"
Ms Margaret Wekesa, a hotelier, argued that the development addresses a long-standing inequality in contraceptive responsibility.
"Women have for a long time been made to bear the 'safe sex' burden, with many female contraceptive options being approved whilst men only have the option of using a condom or getting a vasectomy done, which is so unfair," she said. "We need to share the birth control journey together in equal measure. I am glad that a pill will soon be available for men."
The Phase 1a clinical trial involved 16 healthy, vasectomised men aged 32-59 years with body mass indexes ranging from 21.9-31.1 kg/m². The decision to enrol only vasectomised participants served as an extra precaution to avoid any risk of permanently affecting participants' fertility.
Participants were divided into two groups: the first received initial doses of 10 milligrams of YCT-529 followed by a 30mg dose two weeks later, or placebos. The second group received either 90mg followed by 180mg two weeks later, or placebos throughout.
All participants were required to abstain from alcohol, grapefruit juice, and other medications during the study period. Selected participants also took a third 30mg dose after a high-fat, high-calorie breakfast to assess whether food might affect the drug's tolerability.
Placebo capsules
YCT-529 sodium salt was manufactured by Quotient Sciences in Alnwick under Good Manufacturing Practices conditions. The compound was filled into Swedish orange size 0 hard gelatin capsules at strengths yielding 10, 30, and 90mg of YCT-529 free acid, with matching placebo capsules containing microcrystalline cellulose.
The study, which received approval from the Riverside Research Ethics Committee and the Medicines and Healthcare Products Regulatory Agency, is registered at www.clinicaltrials.gov as NCT06094283.
The positive results from this initial trial have laid the groundwork for a second phase, where men will receive YCT-529 for 28 and 90 days to study safety and changes in sperm parameters.
However, researchers note that the current trial did not assess the pill's efficacy in reducing sperm production. The drug's developer is currently running trials to collect that crucial data.
Like traditional contraceptive pills, YCT-529 is designed to prevent pregnancy but offers no protection against sexually transmitted diseases.
Users would still need to employ barrier methods such as condoms for STD prevention.
The development represents a significant step forward in expanding contraceptive choices and potentially redistributing the responsibility for family planning more equitably between partners. However, further trials are needed to establish the pill's effectiveness before it can become available to the public.
The study was published in Nature journal and represents the first clinical trial of a non-hormonal oral male contraceptive.
