The Male Contraceptive Pill: What's The Big Hold Up?

Along with nuclear fusion and hangover-free booze, few subjects have built more hype than the promise of the male contraceptive pill.

If you search the topic on Google, you’ll be greeted with an endless stream of news stories from past decades proclaiming it’s “just around the corner” or will be “ready in two years!”

So, what’s really going on with male contraception and why the hell is it taking so long? As far back as the late-1970s, scientists have been working away at making this pipe dream a reality. Some 40 years ago, a team of scientists in India created a male contraceptive injection.

The catchily named “Reversible inhibition of sperm under guidance” (or RISUG) works by an injection into the vas deferens, better known as the little tubes that transport sperm from the testicle to the ejaculatory ducts before “the decisive moment.” Although it’s safety has been brought into question, RISUG is low cost, reversible, and highly effective. However, despite numerous revamps and international interest since it was first created, there’s been minimal progress in terms of bringing RISUG to market.

While this method appears to have never really gotten off the ground, there are actually a lot of interesting male contraceptive projects in the works. In March 2019, a clinical trial declared the success of a Phase 1 study looking at the safety and tolerability of a new birth control pill for human men. The pill, known as 11-beta-MNTDC, contains a modified form of testosterone that manages to decrease sperm production while preserving libido.

However, one of the major hurdles to male hormonal contraceptives has been creating a safe and reliable oral form of testosterone or a replacement. Testosterone is broken down rapidly by the liver in its oral form, so much so, it would require guys to dose up several times a day. “Some of the ones that have been created have caused liver damage, so there hasn’t been a wonderful, safe, oral version of testosterone. Without that, we’ve been unable to actually do a pill," Dr Diana Blithe, Program Chief of the Contraceptive Development Program (CDP), told IFLScience.

To help overcome this hurdle, the CDP is taking a deep look into the idea of a contraceptive skin gel for men. The gel contains two main compounds, one of which is the progestin compound segesterone acetate. As with women, if you have a high amount of progestin, the body thinks it's pregnant and doesn’t make a new follicle for the next round of ovulation. In men, a high level of progesterone makes the body think it's making enough sperm and sperm production stops.

Annoyingly, this also lowers testosterone levels in the blood, so the gel also contains this hormone to return serum levels to normal. This means that testosterone levels remain high enough for normal body functioning and – importantly for some – sex drive remains unchanged.

All you have to do is remember to rub a dollop of the gel on your shoulders each morning. Funnily enough, it actually works in a very similar way to the female contraceptive pill. “It actually is fairly similar [to the female contraceptive pill]. I think people don’t really think about it that way because women make one final egg a month and it takes a long time, but men make 1,000 sperm per heartbeat,” explained Dr Blithe.

“Men express a desire to use a contraceptive too. In fact, right now, men account for around 28 percent of male contraceptive use, whether that’s through vasectomies or condoms – neither of which is ideal. Men have expressed a desire to have more options.”

A Phase 2B clinical trial for the gel started in October 2018, and involves real couples testing out its effectiveness as their primary contraception method for a whole year. That said, the gel is still a long way from being available in the pharmacy simply because scientific research can take a hell of a long time. It’s easy to think that a scientific breakthrough comes about in a sudden eureka moment with a flash, bang, and smoke coming out of a test tube, but the reality is years of grant applications, bureaucratic nightmares, then edging through lengthy clinical trials.

“It takes a long time and these studies take a long time to do. We’re doing this Phase 2B and it’s going to take us three or four years from now," said Blithe. "Even if its really great and we have wonderful results then we do a Phase 3 study. We don’t have a lot of products like this for men, so we don’t have a trail blazed that we can follow, so we don’t know what any regulatory body will require for this to get approval.

“You can imagine, this is not going to be available in the next five years,” Blithe concluded. “If we get gung-ho results and support then it could essentially be 10 years before we get to the FDA. That’s something we can foresee happening – if all goes well.” With all that said, the female combined oral contraceptive pill managed to jump headfirst over these barriers and make it onto the market by the 1960s. Scientific challenges have undoubtedly been significant, but there also appear to be some social and cultural factors at play too.

"In short, we need both a change in technology – the development of male LARCs [Long-acting reversible contraceptives] – and a change in ideology – the belief that both women and men should be responsible for contraception – to achieve the more just contraceptive arrangement," Lisa Campo-Engelstein, Associate Professor at the Alden March Bioethics Institute, wrote in the AMA Journal of Ethics.