Are We Any Closer to a Male Contraceptive?

By Ammar Kalia, Guardian UK

30 April 19

The arrival of birth control for men has been ‘10 years away for the past 40 years’ – but the industry is holding back the science

or Pierre Colin, 72, the search for a viable male contraceptive has been lifelong. As with the female hormonal pill, first prescribed (to married women only) on the NHS in 1961, the history of male contraceptive development is long and complicated.

Upon its release, the pill became synonymous with a revolution in sexual freedom. By the time it was made available in the UK regardless of marital status, in 1967, nearly 13 million women worldwide had used it – despite significant potential side-effects, including blood clots and stroke. In Toulouse, Colin, a geologist, wanted to push for a male contraceptive to alleviate this burden. “My female friends were active feminists and so us men wanted to do our part,” says Colin. “We realised it was not enough to just speak about masculinity; we needed to do something to help in the relationships.”

While female contraceptives have proliferated, encompassing the pill, intrauterine devices (the coil), implants and spermicidals, male options are twofold: condoms or a vasectomy. Between 2006 and 2016, the number of vasectomies undergone in the UK fell by 64%, making condoms by far the most popular method.

Trials of an injectable hormone mix of testosterone and progestogens to halt sperm production began in the US in the 70s and showed promising results. In the early 90s, the World Health Organization recruited 271 couples from seven countries to take part in a similar trial. Again, the results were encouraging, resulting in only one pregnancy, yet pharmaceutical companies were unwilling to put up the $1bn (£770m) needed to push a drug into mass-market development, citing the uncertain and untested male market.

Meanwhile, Colin had developed a natural method of male contraception with a local doctor. The “temperature method” involves wearing a jockstrap with an opening through which to push the testicles, apparently increasing their temperature from 34C to 37C – enough to halt sperm production. Users must wear the contraption for 15 hours a day and it takes three months for the temperature to increase reliably.

Colin estimates that more than 200 pairs have been sold. A plastic “ring” that has the same effect is now also available. “People are very interested in the thermal method, because it’s without hormones,” he says. “Lots of women reject the pill because of the side-effects, so we wanted to go down a different path.”

This method may provoke squeamishness, but regardless of whether it catches on, it is symptomatic of male contraceptive research.

“There’s a joke in our field that a viable male contraceptive has been 10 years away for the past 40 years,” says Dr Logan Nickels. As the director of operations at the Male Contraceptive Initiative (MCI) in North Carolina, Nickels has been at the forefront of the recent push to get a male contraceptive product to market. A nonprofit research funder, MCI is developing nonhormonal methods, such as a reversible injectable polymer that blocks the vas deferens (the duct that conveys sperm from the testicles to the urethra), and herbal compounds, including one made from the plant Justica gendarussa. “I really feel in the past five years – and even more so in the past 18 months – there’s been an enormous change in the way male contraceptives are talked about by the public,” says Nickels. “It’s largely due to younger generations who have been asking why these contraceptives haven’t been developed yet – they want to engage in the family-planning conversation much more.”

That sentiment is echoed by Aaron Lockhart Jr, who is taking part in a year-long global trial of a hormonal gel contraceptive for men run by the University of Washington in Seattle. “I’ve watched my wife be on different forms of birth control for over 10 years and they can play havoc with the female body,” he says. “She’s constantly negotiating which hormones might work, so I thought it was time I took some responsibility.”

Trials for the male pill have proved difficult, due to differences in how hormones are metabolised in men and women, but there are increased hopes for this gel, which is already used as a way of treating testosterone deficiencies in the US. The alcohol-based solution is self-applied daily, making it markedly more accessible than injectable methods, which required medical supervision. “The demand for recruitment in this trial was really high,” says Lockhart: there were thousands of applicants for only 40 places. “There should be more of a push for men to do this, to get rid of their fears around their masculinity and virility, when actually it’s nothing to do with that.”

Attitudes seem to be shifting. A YouGov poll from January showed that a third of British men would be willing to take a pill – the same proportion of women who take hormonal contraception – while almost 80% of the adults surveyed see shared responsibility of contraception as a positive development. A global survey of 9,000 men from 2012 showed that 55% of respondents would be willing to try “a new form of hormonal contraception”.

“The reality is that 40% of pregnancies globally are unplanned, and that creates an enormous economic and societal burden,” says Dr Stephanie Page, the leader of the gel trial in Seattle – not to mention the estimated 25m unsafe abortions that take place every year. “By not giving men options, we’re excluding half the population from helping solve that important problem. One man can father a lot of pregnancies, so it could be very impactful.”

For men and women, offering choice of contraceptives is crucial, say scientists – whether that means gels, pills or underwear. “There won’t be one perfect contraceptive for all men and there won’t be a single contraceptive for one man throughout his entire life,” says Nickels.

The options for men could include Colin’s adapted underwear, which he recently had patented. “The thermal method is actually a studied phenomenon, and if one can keep that temperature for long enough it does provide a reversible means of contraception,” says Nickels. “But we need to make contraceptives that will provide as few barriers as possible, as well as making it fun and easy. These sort of things shouldn’t impact daily life or be difficult to use.”

Yet without interest from pharmaceutical companies, it could be decades before a viable product makes it to market. “When women use contraceptives, they are preventing a potentially life-threatening condition: pregnancy,” says Page. “But when men use contraceptives, the risk-benefit equation is different, because there’s not necessarily any individual risk to the man. We might see from studies that men are willing to take new contraceptives, but pharmaceutical companies still see the potential market for them as a risk.”

Historically, though, sexist male attitudes have played a part in halting the progression of contraceptive trials. In the 70s, hormonal tests in Brazil were stopped because patients’ potassium levels fell; the issue was resolved, but further trials did not take place, prompting the leader of the research, Dr Elsimar Coutinho, to suggest later that men were “very afraid of losing virility”. In 2016, an injectable hormone trial was halted after 20 men dropped out due to increased libido, acne and depression – common side-effects of the female pill – leading to accusations of hypocrisy among men.

At MCI, Nickels is using online crowdfunding and grants to get around the reliance on pharmaceutical companies for initial funding. “We’re hoping that by employing funding models like philanthropy and other private investors, we can find new ways of bringing these products to market, while ensuring they are still derisked and scientifically sound,” he says. Last year, MCI raised $1.8m; it is hoping that, with sufficient funding to secure preliminary trials, it can take its results to pharmaceuticals for further trials.

Despite the shortage of funding, significant developments are being made. A month-long trial of a hormonal pill in March by the US’s National Institute for Child Health and Human Development was successful in preventing pregnancy and showed no significant side-effects. “I hope this trial is a turning point,” says Dr Diana Blythe, the head of the programme. “We’ve had tremendous interest, since there has been 50 years of no change for male contraception and now things are developing.”

The next steps include longer trials on a larger group of men to verify sperm reduction, then the recruitment of couples to use the pill as their sole method of contraception. Like many drug trials, the process will be long, expensive and probably face regulatory battles. The cost of the final product is still a long way off considering. “I keep having to depress everybody by saying that if this works really well – which we’ll know in three to four years – phase three then needs to be three to four times larger,” Blythe says. “That whole process would take at least a decade, but each step forward is all the more significant for that.”

Those involved in the studies hope their efforts will serve future generations. Nickels says he often thinks of his five-month-old son: “The timeline for these options means he’ll be one of the first users that has options on the market. I’m hopeful that I can set the stage for him and that his relationships will be empathetic, where he can really engage with his partner on what is a key piece of any relationship: deciding if and when you want to have children.”

Lockhart, however, may be forced to make a decision sooner. “I’d love to stick with this method if it works,” he says, “but I know there’s still a long way to go, so we’ll probably have our kids in five years or so and then, once our family is complete, I’ll just get the snip.” Colin regrets not having a vasectomy after his two children were born in the 70s, since the science for male contraceptives has progressed far slower than he had anticipated. “I’m too old for it now,” he says. “The contraceptives will be for my grandchildren to pursue.”