British men will become the first people in the world to test a new type of male contraceptive pill.
Male contraception has been sought for several years and has historically been focused on suppressing testosterone levels.
However, a drug called YCT-529 works by stopping the production of vitamin A to create temporary, and reversible, infertility.
A phase one trial of 16 men has now been launched by US firm YourChoice Therapeutics and the trial will take place at a clinic in Nottingham.
The participants will be the first in the world to get a hormone-free male birth control pill.
The current female pill is hormonal and has known side effects such as increased risk of blood clots, acne and mood swings, among others.
‘Holy grail of contraceptive research’
Animal studies have shown the new drug to be effective at stopping pregnancy and the small trial will test if the drug is safe in humans.
The trial will be a double-blind placebo investigation with half getting the drug and the other half only getting an inert imitation. Data is expected by mid-2024 and if promising will likely result in a larger phase two trial.
“A male birth control pill has been the holy grail of contraceptive research and development for decades, and YourChoice Therapeutics is positioned to be a pioneer in this field,” said Maryanna Saenko, a co-founder and partner at Future Ventures.
“YCT-529 represents the first hormone-free therapy, finally enabling men to have an effective birth control option.”
The drug is a retinoic acid receptor-alpha inhibitor and works by stopping the stimulation of sperm cells.
It also blocks the release of sperm from these cells, offering a two-pronged infertility-inducing approach.
‘The world is ready’
Animal studies indicate it is 99 per cent effective at stopping pregnancy and 100 per cent reversible.
Professor Gunda Georg of the University of Minnesota, who has led the development of the new drug, said: “The world is ready for a male contraceptive agent and delivering one that’s hormone-free is simply the right thing to do.”
Evidence from female hormonal contraceptives and hormonal male versions shows there can be side effects caused by synthetically altering sex hormone levels.
Akash Bakshi, co-founder and chief executive of YourChoice Therapeutics, believes a protein pill, not a hormone drug, will be more attractive to men.
“The dearth of options reinforces the centuries-old view that pregnancy prevention is ‘a woman’s responsibility’,” he said.
“It’s not, and we’re committed to advancing the first hormone-free birth control pill for men that’s effective, convenient, and temporary.”