The Independent on Saturday

Promising strides in male contracept­ion

Studies suggest two new products could be on the market in 2028

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RESEARCHER­S have launched two of the most promising studies in male contracept­ives this week – 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 centres 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.

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, said the gel and pill she was working on were the most promising – if not 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 “peaks and troughs” in mood.

“We have shown that it suppressed the sperm if the man applies it every day; that it would be 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 centres 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 by 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,” said Wang.

As these trials get going, 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, envisionin­g 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 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 (intra-uterine device), 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 gynaecolog­ist 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.”

Last, 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 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 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.

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”. – Daily Mail

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