Six decades after the invention of the female pill, a male hormonal contraceptive is on the horizon as a groundbreaking clinical trial gets under way.
A couple in Edinburgh will be among the first in the world to rely on a hormone-containing gel as their sole form of contraceptive for the next year.
James Owers, 29, and Diana Bardsley, 27, are among 450 couples who will test the gel in a trial starting on Saturday that scientists anticipate will demonstrate an effectiveness equivalent to the female pill and that could transform social attitudes towards reproductive control and pregnancy.
“Men need more options. Right now it’s very easy for men to say ‘it’s not really on me’,” said Owers, a PhD student. “If the gel becomes widely available, it’s much more stark that by not taking that option, you actively made the decision to not take responsibility.”
“I think it’s a massive deal,” said Bardsley, a social researcher. “It gives the chance for men to have this great combination of autonomy and more responsibility as well. That can only have a positive impact on the relationship between men and women in society.”
The gel, which is applied daily to the chest, shoulders and upper arms, contains a mixture of progesterone and testosterone. The progesterone switches off sperm production in the testes and the testosterone offsets a drop in testosterone that this causes.
Without adding testosterone back in, men get unpleasant side-effects such as low mood, weight gain and a slump in libido. Because testosterone is metabolised so quickly in the liver, it can’t be delivered effectively via a pill, and this has proved the major obstacle to developing a male hormonal contraceptive.
Recently, though, there has been significant progress. A trial in 2016 of a hormone jab demonstrated effectiveness rates close to those of the female pill, although some participants encountered other problems including acne and depression.
Scientists hope the gel version, which is being tested at centres in the UK, Sweden, Chile and Kenya, will prove easier to use and have fewer negative side-effects.
The drug comes in a pump something like a toothpaste dispenser and has the consistency of hand sanitiser. The man applies one dose to each shoulder, upper arm and pec each morning.
A slight inconvenience is that the female partner has to avoid contact with this part of the body (“unless Diana wants to grow a beard,” Owers said) to prevent a second-hand dose of testosterone. So men are advised to either shower before bed or wear a T-shirt at night.
After using it for six weeks, Owers learned that his sperm count had dropped to almost zero. He said he felt “quite excited” rather than anxious on getting the result from the trial’s head nurse.
It would take a similar length of time for sperm production to ramp back up to normal, meaning a missed dose for a few days would not result in a significant chance of pregnancy, unlike with the female pill.
After nine weeks on the gel, the side-effects have been minimal: some small spots on the lower back, a slightly increased sex drive and putting on about 2kg have been the only notable changes. “The overarching thing is that I feel it’s had very little impact on my life,” he said.
If results of the year-long trial are encouraging, the scientific team hope there will be interest from pharmaceutical companies to take the product to market, and this could happen within four to five years.
“Before the pill came into existence we couldn’t have predicted the effects it would have in society,” said John Reynolds-Wright, a clinical research fellow at Edinburgh who is leading the trial. “In the same way, I don’t think we can really accurately predict the effect this will have. But like the pill, I think it will be largely for the positive.”
• The trial is recruiting men aged between 18 and 50 who are in a stable relationship with a woman aged between 18 and 34. For more information call 0161 276 3296 (Manchester) or 0131 242 2669 (Edinburgh).
