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After decades of false starts, researchers say they are finally making progress on a long-acting, reversible birth control option for men.
The trial product is a hormone gel that men apply to their shoulders once a day. Over time, it inhibits the formation of sperm in the testicles.
The gel was developed by the National Institutes of Health and the nonprofit People's Council and takes the same approach as the female birth control pill. It uses two hormones: testosterone, progesterone and the male sex hormone testosterone. Nestorone stimulates the production of testosterone in the testes and thus the production of sperm.
But testosterone has many functions in the body: it is responsible for muscle maintenance and libido, for example, and men need some in the bloodstream to function normally. The gel replaces them enough to keep them healthy, but they also produce enough sperm to get someone pregnant.
Since 2005, researchers have been developing and refining the size and concentration of the gel. With this latest experiment involving more than 300 couples, you'd think they got it right.
A normal sperm count is between 15 million and 200 million sperm, and research shows that a sperm count of less than one million is enough to prevent pregnancy.
as if Clinical trial86% of men using the gel achieved the lowest sperm count within 15 weeks. For some, it worked quickly, suppressing sperm production within four to eight weeks.
We are very pleased with the results. “The combination seems to provide better and faster suppression than we expected,” said Diana Blythe, head of the NHIH National Institute of Child Health and Human Development, who presented the trial's results at the Endocrine Society's annual meeting this week. in Boston.
Blitz declined to say whether there were any unintended pregnancies during the trial. The researchers hope that the final data will be published in a medical journal, and she said she did not want to give away the results.
“I would expect it to be similar to hormonal birth control pills. And then I can say it's very, very good,” she said.
In common use, they have birth control pills, rings and pads Failure rates About 7%, which means that 7 out of 100 women will get pregnant if they use the method for a year. Condoms have a failure rate of about 13%.
The gel has other advantages over female birth control. For example, if a woman misses a day or two from the pill, she may ovulate.
If a man's sperm is completely suppressed by the gel and is not used for a day or two, the hormones will start to recover, but it will take 8 to 10 weeks for the sperm count to recover. Pregnancy.
Blitz said that in clinical trials, researchers don't look at mood swings and depression in women who get birth control pills.
“I would say a small percentage have mood swings that they don't like, but that number is relatively small. And we're surprised that it's so small,” she says.
The World Health Organization has tested injections that used a similar combination of hormones. Although the approach seems effective, the Study registration has stopped earlyIn the year In 2011, the shot caused several side effects, including severe depression.
Blithe said this was because the hormones were being cleared at different rates when they were injected. The gel creates a reservoir of hormones that accumulates in the skin and is slowly released.
“That fluctuation isn't really happening, so we're not creating fluctuations,” she says.
Matthew Trevino, 35, of Sacramento, California, participated in the study. First thing in the morning, he rubs a little gel on each shoulder and says it's become as normal as showering and brushing his teeth.
Apart from the slight weight gain, he had no complaints, he said. If anything, his libido increased.
“I just experienced an increase in sex drive,” he says. The “Fold” podcastDeveloped by the University of California, Davis, which is one of the studies. “Maybe I'm lucky, but I hope that's the case with most of the participants. If so, it will certainly change contraceptives in general.”
To participate in the study, couples had to be in a committed relationship, and signed a two-year commitment to the research.
Men are warned that they may experience several side effects from the gel, including dry or oily skin, hair growth or loss, hair growth or loss, and mood swings.
For Trevino's partner Emily Fletcher, 28, participating in the research meant giving up her own birth control — an IUD — and taking a big leap of faith when the U.S. Supreme Court overturned Roe v. Wade.
“I was worried,” she said. There was still a thought in my mind, 'Maybe if the medicine doesn't work and she gets pregnant, this could be a problem.' ”
Fletcher and Trevino, both researchers at UC Davis, ultimately felt it was important to participate in the study.
Trevino told the podcast that he has long been interested in male contraception. For him, it is not fair for his partner to bear the burden of birth control.
On average, women ovulate once a month, while men produce about 1,000 sperm every second.
“Maybe the burden is on the wrong side,” Trevino said. “I don't think it's fair to rest solely on the women.”
After men stop using the gel, their sperm count will return to normal within two or three months. After the recovery phase of the trial, many participants went on to become fathers, proving that the method is completely reversible, Blythe said.
This is a big step. Currently, the only birth control options for men are condoms, which have a high failure rate, and vasectomy, a surgical procedure, which is difficult to reverse.
The researchers have begun discussions with the US Food and Drug Administration about how to test the gel in a final trial. No male contraceptive method has yet been developed, Blythe said.
Typically, drugs that reach this point must be compared head-to-head with a placebo. Dr. Christina Wang, co-principal investigator on the trial who focused on sperm at UCLA Harbor Medical's Lundquist Institute, said testing a true placebo in research whose goal is to prevent pregnancy would be inappropriate. middle.
If the researchers get the FDA nod for the trial, they hope to begin the final phase of the trial in 2025. It takes another two years and Wang They said they would probably expand the study to more locations and recruit more couples.
Large experiments often require significant investment. Blyth said she hopes to get interest from pharmaceutical companies.
Dr. Brian Nguyen, an obstetrician-gynecologist at the University of Southern California who was involved in helping participants with social and behavioral needs during the trial, said he is looking forward to the gel coming to market and bringing a new era. Gender equality in birth control.
“We often assume that men don't know or don't want to be involved. But when you think about men who are intimate partners, how does a female partner hide the fact that they are either sick, or have abnormal bleeding, or have mood swings?” he said. “It's a very unique couple-driven medicine.”