Hormone-free male birth control pill shown safe in human trials, raising hopes for new contraceptive option
The drug, designed to reversibly reduce sperm count, was tested on 16 male volunteers. This development could offer men a new alternative to condoms or vasectomy, which have long been the only options for male contraception.
Prior attempts at creating a male contraceptive pill often resulted in unwanted effects such as weight gain, acne, mood swings and changes in sex drive.
Meanwhile, although women have a range of birth control options, these also typically come with potential side effects. More than a third (37 per cent) of woman report a negative experience will a contraceptive pill.
What sets this new pill apart, scientists say, is its hormone-free formula, which may mean far fewer adverse effects compared to earlier efforts.
'Since nearly half of all pregnancies in the US and worldwide are unintended, there is a critical need for additional contraceptive options for men and women,' researchers from YourChoice Therapeutics explained.
This contraceptive uses a chemical called YCT-529, aiming to block vitamin A metabolites from binding to certain receptors in the testes, thereby stopping sperm production.
Professor Alan Pacey, an andrologist at the University of Manchester who was not involved in the study, told BBC Radio 4's Today programme: 'This molecule targets a compound which is related to vitamin A, retinoic acid, and we have known for a long time that this compound is important in how sperm are produced in the testis, making it the perfect target for a male contraceptive pill. It is able to inhibit that process without altering the sex hormones, which give men a sex drive.'
Previous animal studies using this compound have shown that it can induce reversible infertility without causing side effects.
In these most recent trials, the 16 male volunteers aged 32 to 59 took the drug twice in increasing doses—10mg, 30mg, 90mg, and 180mg—while some received a placebo to compare results. Side effects and hormone levels were monitored for 15 days.
The authors of the study wrote: 'Administration of single oral doses of 10–180 mg YCT-529, fasted, and 30 mg, fed, is well tolerated by healthy male subjects. YCT-529 does not demonstrate an adverse cardiac safety profile, or change in haematology, coagulation or serum chemistry parameters, hormone or pro-inflammatory cytokine levels, sexual drive and mood, and shows good bio-availability (with no clear food effect).'
Dr Pacey described the results as an 'exciting step forward,' but warned that the medication has yet to be tested in the real world to confirm its effectiveness in preventing pregnancies.
He pointed out, 'It takes three months to produce sperm from start to finish and so if you were to start taking any pill, not just this one, you would need to have the sperm that are currently on the production line to be moved from the system. So, there will be a lag between starting to take the pill and it having its full contraceptive effects.'
He also pointed out that bringing the pill to market remains a significant financial hurdle.
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This small trial involved 16 male volunteers who took the drug twice at increasing doses — either 10mg to 30mg or 90mg to 180mg. Some men took placebo pills for comparison. The participants were monitored for 15 days for any effects on normal hormone levels, inflammation (signs of cell damage), kidney and liver function, abnormal heart rhythms, sexual desire and mood. No changes were detected in the natural hormones in the body. There were also no lasting effects on liver and kidney function and no signs of cell damage. No dangerous abnormalities of heart rhythm were detected, and the participants reported no changes in mood or sexual desire. However, participants only took two doses of the drug and were only followed up for 15 days. The authors say in the paper that a larger phase two trial is underway, which will test the drug in a greater number of men. This will then be followed by phase three trials in hundreds of men where the effectiveness, reversibility and side effects of longer term use of the drug will be assessed. These are the hurdles which have prevented other approaches from being made widely available. Why past male contraceptives have failed At present, there are no commercially available contraceptive methods for men that are not only safe and effective at preventing pregnancy, but which also allow sperm production to be turned off and on again at will. While condoms have few side effects and are used at will, they have a relatively high failure rate (resulting in pregnancy about 12 per cent to 18 per cent of the time with typical use). A vasectomy, which severs the tube connecting the sperm-producing testes to the rest of the male reproductive organs, is very effective (more than 99 per cent) and safe — but it's not easily reversible and requires a minor operation. There have been previous attempts (and some ongoing) at producing a reversible method of contraception for men. Some have proven to be effective at stopping sperm production or preventing sperm from exiting the male reproductive tract. However, they haven't moved to the stage of commercial production, often because of unwanted side effects. Most of these attempts used one of two main approaches to prevent pregnancy. One method involves injecting a substance into the vas deferens (a tube leading from the testes to the urethra). This substance filters out and damages sperm during ejaculation. This substance can be flushed out through a minor procedure if the man wishes to become fertile again. The drawback of this method is that it requires a minor surgical procedure (an injection into the scrotum) and that the man has to have a further procedure to reverse its effects. 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