By Brenda Goodman | CNN
After many years of false starts, researchers are finally making progress in developing a long-acting and reversible approach to contraception for men.
The experimental product is a hormone gel that men rub on their shoulders once a day. Over time, it blocks sperm production within the testicles.
Developed by the National Institutes of Health and the nonprofit Population Council, the gel takes an identical approach to contraception pills for girls. It uses two hormones: Nestoron, a progestin, and testosterone, the male sex hormone. Nestoron suppresses the production of testosterone within the testes and thus the event of sperm.
However, testosterone has many functions within the body: it's accountable for muscle maintenance and libido, for instance, and men need a few of it of their bloodstream to operate normally. The gel replaces enough to maintain them healthy, but not a lot that they produce enough sperm to impregnate someone.
Since 2005, researchers have been working on formulating and refining the gel's dosage and concentration. They are convinced that they’ve succeeded on this latest test, through which greater than 300 couples took part.
The normal sperm count is between 15 and 200 million sperm per milliliter of semen. Studies have shown that a sperm count of lower than 1 million per milliliter is low enough to stop pregnancy.
In a clinical study86% of men achieved this low sperm count after 15 weeks of using the gel. For some, it worked even faster, suppressing sperm production inside 4 to eight weeks.
“We are simply thrilled with the results. The combination appears to produce better and faster suppression than we expected,” said Diana Blithe, director of the NIH's National Institute of Child Health and Human Development, who gave an update on the study results this week on the Endocrine Society's annual meeting in Boston.
Blithe declined to say whether any unintended pregnancies occurred throughout the study. The researchers hope to publish the ultimate data in a medical journal, and he or she said she didn’t wish to disclose the outcomes.
“We expected it to work similarly to hormonal birth control pills. And all I can say is that it is much, much better,” she said.
When used typically, contraception pills, rings and patches for girls Failure rates of about 7%, that’s, 7 out of 100 women who use this method for a yr will turn out to be pregnant. For condoms, the failure rate is about 13%.
The gel also appears to produce other benefits over contraception. For example, if a lady misses the pill for a day or two, she may ovulate, increasing the possibility of an unwanted pregnancy.
If a person's sperm production is totally suppressed and he doesn’t use the gel for a day or two, his hormone levels will begin to get better. However, it takes about 8 to 10 weeks for a person's sperm count to return to a level that will allow pregnancy.
Blithe says that in clinical trials, researchers also didn’t observe the mood swings and depression that may occur in women when taking contraception pills.
“I would say there is a small percentage who have mood swings that they don't like, but that's a relatively small number. And we were actually surprised at how few there are,” she said.
The World Health Organization tested injections with an identical combination of hormones. The approach seemed effective, however the Enrollment was terminated prematurelyin 2011 since the injections caused too many negative effects, including severe depression.
Blithe said it is because the hormones are broken down at different rates when injected. The gel appears to accumulate a concentration of hormones within the skin, making a reservoir that’s released more slowly.
“That fluctuation doesn’t really happen, so we’re not causing ups and downs,” she said.
Matthew Treviño, 35, of Sacramento, California, participated within the study. He rubs just a little gel on each shoulder very first thing within the morning and says it has turn out to be as natural to him as showering and brushing his teeth.
Apart from a slight weight gain, he said he had no complaints. His sex drive had even increased.
“I only experienced an increased libido,” he said the “Unfold” podcastwhich is produced by the University of California at Davis, which was also one in every of the study sites. “Maybe I'm just lucky, but I hope that's the case for the majority of participants. If that's the case, it will definitely change contraception overall.”
To take part in the study, couples needed to be in stable relationships and commit to participating within the research for a period of two years.
Men are advised that the gel could cause quite a few negative effects, including dry or oily skin, increased or decreased libido, hair growth or loss, and mood swings.
For Treviño's partner, Emily Fletcher, 28, participating within the study meant giving up her own contraception method — an IUD — and taking an enormous leap of religion, all at in regards to the time the U.S. Supreme Court overturned Roe v. Wade.
“I was worried,” she told Unfold. “There was still this thought in the back of my mind that maybe there could be a problem if the medication didn't work and I got pregnant.”
Fletcher and Treviño, each researchers at UC Davis, ultimately felt it was vital to take part in the study.
Treviño said within the podcast that he has long been considering a contraceptive for men. He doesn't think it's fair that his partner has to bear the burden of contraception.
“Maybe the burden is on the wrong side,” Treviño said. “I think it's somehow unfair that only women are suffering.”
When men stop using the gel, their sperm count returns to normal inside two to 3 months. After the study's recovery period, lots of the participants became fathers, proving the strategy is totally reversible, Blithe said.
This is an important step forward. At the moment, the one contraceptives available for men are condoms, which have a high failure rate, and vasectomy, a surgical operation that’s difficult to reverse.
The researchers have begun discussions with the U.S. Food and Drug Administration to debate find out how to test the gel in a final trial. No male contraceptive method has yet gotten that far, Blithe said.
Normally, drugs that make it to this stage should be compared on to a placebo. But testing a real placebo in a study whose goal is to stop pregnancy would simply be unethical, says Dr. Christina Wang, one in every of the study's leaders who makes a speciality of male reproductive biology on the Lundquist Institute at UCLA Harbor Medical Center.
If researchers get the green light from the FDA to start out a trial, they hope to start the ultimate phase of testing in 2025. It can be a couple of more years, and Wang said they are going to likely expand the trial to more sites and recruit more couples.
Large trials also typically require significant investment. Blithe is confident that pharmaceutical corporations can be interested.
Dr. Brian Nguyen, an obstetrician-gynecologist on the University of Southern California who supported participants with their social and behavioral needs throughout the study, says he is happy to bring the gel to market and usher in a brand new era of gender equity in contraception.
“We often think that men are unaware or don't want to be involved. But when you think about men who are in very close relationships, how can a partner hide the fact that she is in pain, has abnormal bleeding or mood swings?” he said. “It's a couple-specific medication that is very special.”
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