A blob of gel on the shoulder every morning: new gel may give men control over their fertility
A hormone-based gel designed to reduce sperm production is at the trial stage: The NES/T gel contains a mixture of progestogen and testosterone. The progestogen switches off sperm production and the testosterone compensates for the drop in testosterone this causes."
A male contraceptive gel currently being trialled could signal a historic medical breakthrough that allows men take equal responsibility for birth control.
The ground-breaking global study (NES/T) is taking place at Saint Mary’s Hospital, Manchester, as well as in Edinburgh and five other locations worldwide — US, Sweden, Italy, Kenya and Chile.
Dr Cheryl Fitzgerald, consultant gynaecologist at Saint Mary’s Hospital and study lead at Manchester University NHS Foundation Trust, says the hormone-based gel is designed to reduce sperm production, without affecting libido, and works in a similar way to the female pill.
“The underlying principle is very similar. The NES/T gel contains a mixture of progestogen and testosterone. The progestogen switches off sperm production and the testosterone compensates for the drop in testosterone this causes."
The search for the holy grail of a male contraceptive pill has been long underway but it has been notoriously difficult to develop. Dr Fitzgerald says other research — beyond hers — is investigating different ways of delivering male hormonal contraception, as well as ways to block sperm flow.
“NES/T is one of the furthest along,” she says, confirming that recruitment for phase two of the trial continues until the summer, when recruitment will begin for phase three. The trial is funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development in collaboration with Population Council, an NGO.
Explaining that testosterone can’t be given to men in pill form/orally, Dr Fitzgerald says previous trials have looked at injectable male hormonal contraception. “But people don’t generally like needles, whereas our trial gives the drug through the skin. There’s a big drive to deliver many drugs transdermally now — it is often a bit safer for the liver.”
Men participating in the trial are required to rub the clear gel into their shoulders or chest area once a day. “Depressing the top of the container delivers a set amount of gel. They put one blob on each shoulder. It dries very quickly,” explains Dr Fitzgerald, who says it takes some weeks for sperm production to go down.
For up to 20 weeks, couples are required to continue using their normal contraceptive method, in conjunction with the hormone gel. When the male partner’s sperm count falls below the required level, couples are asked to rely on the gel as their sole form of contraceptive for the following 12 months. During this period sperm count is checked monthly to ensure it’s still low.
After the 12 months, the recovery phase can last up to six months, during which the study team does follow-up appointments to ensure the man’s sperm levels have returned to normal.
Throughout the trial, blood tests check for side effects, for example, high blood pressure or if testosterone levels are too high/low. Men are recommended to apply the gel in the morning after showering. “For about four hours after application, we advise no close body contact without clothes on, which is why we don’t recommend applying it at night – if it rubs off on the woman, it could potentially be absorbed,” says Dr Fitzgerald, adding that the trial has also monitored female partners to ensure they have no side-effects.
“In satisfaction data — whether it gets in the way of the couple’s life or is a nuisance — we’re finding it seems to be really well tolerated and acceptable. We’re seeing very few side-effects.”
She confirms it has been difficult to get data on whether the hormonal gel has impacted men’s mood. While the trial opened in Manchester in April 2019, much of the study — involving approximately 420 couples worldwide — has been conducted during the pandemic. And the pandemic affected most people’s moods.
Dr Fitzgerald — both of her parents come from Ireland — says so far the NES/T gel seems to be at least, if not more, effective than the female contraceptive pill. “Our general feeling is it’s very effective, very well tolerated and people like using it.”
While men are recommended to apply the gel at about the same time daily, the method is “a bit more forgiving of the odd forgotten day” than the contraceptive pill, she says. “You can rebound from the pill very quickly so if you miss a pill it can be a problem, whereas that’s not the case with the gel.”
And just as with the pill, a barrier contraceptive — for example, a condom — is a better contraceptive option for casual sexual encounters. “Like the pill, you can’t just think ‘I’ll take it tonight’. You have to be taking it a while to control the ovaries. It’s the same with the gel — you have to take it a while to control sperm production.”
But with contraception long seen as a female concern, women will, without doubt, ask the question — even privately — ‘can I trust him to take it?’ Dr Fitzgerald says there’s more expectation now that men step up in the event of unplanned pregnancy. “Years ago men could run away from pregnancy. Not now, with DNA [confirming paternity]. A man can certainly not walk away financially.”
She points out that while women have historically shouldered the contraceptive burden, men have had to trust women around this. “With this method, men can share responsibility for contraception and women have to trust. A male contraceptive gives men a lot of control over their fertility that they didn’t have previously.”
Does she see LARC (Long-acting Reversible Contraception) anywhere on the horizon for men? She doesn’t dismiss the idea. “It’s not out of the realms of possibility that LARC could happen for men.”
Manchester-based Dan Glastonbury, 35, and his 32-year-old wife, Emily, completed the trial in May 2020.
For 18 months, Dan — who along with Emily works in entertainment — put the gel on every morning after his shower. “I kept it next to my toothpaste. I remember to brush my teeth everyday so I could remember to put on the gel.”
Explaining that he had cancer aged 19, he says: “I’m alive today thanks to people who took part in medical trials. When I got the all clear, my mum gave me a book on things to do before you die and one was to take part in a medical trial. So when Emily saw online about NES/T, she said here’s one you could do.
“She’d been on some form of hormonal contraception since she was 16 and this meant she could take a break.”
Emily was delighted not to have to think about contraception every day. “It was a chance to get back to myself. On the pill, I had mood swings. I didn’t feel like I was in the natural rhythm of my body.”
Admitting he had some concerns about putting an experimental product on his body, Dan says Dr Fitzgerald allayed his worries.
“She explained I wasn’t introducing anything new into my body. I was putting in something that was already there to make my body reduce sperm. That helped me feel safe and secure.”
Emily didn’t have these concerns, being “so used to hormonal contraception”, nor did she worry Dan might forget to apply the gel.
She didn’t worry either that the contraceptive gel mightn’t work. “It wasn’t a real issue. We were planning on having children anyway. It would just have happened a bit sooner. I was OK with that.”
Dan says it felt good to relieve Emily of having to take a drug that negatively affected her.
“For the first time this allows women not be the sole bearers of responsibility when it comes to contraception. It felt nice to be part of something that gives women more freedom.”
He came off the gel in October 2020 and within months his sperm count returned to pre-trial levels. The couple started trying for a baby and got pregnant in May 2021 — Baby Jack was born last month and is, says Dan, “the loveliest little thing I’ve ever met”.
Should the gel come to market, he encourages other men to use it if they’re in a long-term relationship and want to give their partner a break from the responsibility of contraception.
“It’s way easier to put on a gel than take the contraceptive pill. There are no side-effects – whereas there’s such a long terrifying list of side-effects for female hormonal contraception.”
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