Government-funded researchers today launched two of the most promising studies in male contraceptives – which could bring two products to the market in 2028.
LA Biomed, a non-profit research group, has an oral contraceptive that has proved safe in preliminary trials, and a contraceptive gel, applied daily to the shoulder, that has both proved safe and effective in extensive trials.
Now, in alliance with the National Institutes of Health, their team is overseeing trials of the gel in nine centers around the world, while testing the pill’s effectiveness in trials at their base in California.
Despite significant public interest for a male alternative to the Pill – almost 60 years after it was approved for women – this is one of the few concrete moves to actively move a product closer to consumers.
LA Biomed is testing a contraceptive gel and a pill for men to use. The gel has proved effective and safe in six-month studies. The pill is in earlier stages; so far it has proved safe, but not yet effective. Pictured: file image of a female contraceptive
Currently, the only options for male contraception are condoms or a vasectomy – as well as the ill-advised and highly ineffective ‘withdrawal method’.
LA Biomed’s lead researcher Dr Christina Wang, of UCLA, told Daily Mail Online the gel and pill that she is working on is one of the most promising – if not one of the only – promising options to date.
The gel, a combination of testosterone and progesterone, has proved just as effective as any female contraceptive, after six months of tests.
It is applied to the shoulder, since this is the area deemed least likely to come into contact with women and/or children. Despite the rub risk, Dr Wang said the benefit of a gel is that it is absorbed very quickly into the blood vessels beneath the skin, and then is very gradually released into the body, lowering the risk of ‘piques and troughs’ in mood.
‘We have shown that it suppressed the sperm if the man applies it every day; that it would be very, very unlikely to cause pregnancy to a female partner, just like a female contraceptive,’ Dr Wang said.
Now, the gel will be given to men in nine centers across four continents – North America, South America, Africa, and Europe (excluding Asia because it is too far away for FDA inspectors to monitor the two-year trial).
By the end of it, they aim to prove that men who use it have a negligible risk of pregnancy with a female partner solely using the gel.
They have high hopes for the pill, too, now that early trials have shown it is not harmful.
‘Our initial studies [for the pill] were just on safety, and it passed those stages.’
As these NIH-funded trials get going, Dr Wang also hopes to make some progress with an injection, akin to ‘the depo-shot’, which women can get every three months to prevent pregnancy.
Dr Wang envisions a version for men that could be administered annually.
‘What we are trying to do is to have quite a few options [on the market],’ Dr Wang said.
‘There is lots of interest from the general public but there [are] very, very few studies that are developing contraception for males.’
Unlike the race to cure Alzheimer’s, cancer, and high blood pressure, the biggest pharmaceutical companies are noticeably absent in the race to dose up men with contraceptives instead of women.
According to Dr Wang there are three major obstacles.
First, of course, is business.
‘Big companies are also making the female contraceptive, like the Pill and IUD, so why would they want competition in their company? Why compete with themselves?’
Second, and tied to the first, is a question that even Dr Wang is still grappling with: ‘who will be the holder?’
‘For females it’s easy: you go to your gynecologist to get your pill or your IUD put in. But for the male… who are you going to send them to? I think probably your primary care, but it could be urologist or endocrinologist. That is something that is not clear.’
Lastly, there is the issue with any drug in development: how do you make sure it has the least side effects as possible? With something like a contraceptive, used by millions if not billions of healthy people, that is key.
The safety studies are ensuring that any potential contraceptive treatment for males would have the lowest risk of mood swings and physical reactions.
While those side effects are common to all female contraceptives, manufacturers insist that we’re in a different age now: the threshold for safety is different – and not retroactive – and going back to the drawing board now isn’t the most lucrative course of action.
Happily, for men, Dr Wang says the pill and particularly the gel seem to have barely any impact on the users.
But, she adds, ‘we will have no idea until it hits the market’ – slated for 2028.