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An elusive medical advance could finally be within the reach of science. The researchers officially launched this week the first large-scale clinical trial of a men's topical contraceptive gel.
• Daily male contraceptive pill looks promising after a human test
• The real reason a study on male contraception was discontinued
The test, funded by the National Institute of Health Children and Human Development (NICHD), is expected to host 420 young and healthy couples. The couples will be recruited from nine places of study in seven countries around the world, including Chile, England, Scotland, Kenya, Italy and Sweden. However, the first group of volunteers will come from the United States, Seattle, California and Kansas.
The gel itself is a combination of a new drug called Nestorone, a hormone progesterone and testosterone. Although still dependent on other contraceptives, male volunteers will apply NES / T gel daily (on the arms and shoulders) for approximately 20 weeks.
Once the sperm count has fallen to a point corresponding to infertility, participants and their partners should use the gel only to prevent pregnancy next year. After one year, they will stop taking the gel and will be examined for another six months to make sure the effects on the sperm count are reversible.
The basic principle of freezing is simple, according to Christina Wang, a researcher at the Institute. Los Angeles Biomedical Research and Study Leader. The drug Nestorone and other progestins are already used regularly in many women's contraceptives, including the badl ring.
But when progesterone is used alone in humans, it reduces the number of spermatozoa and causes a decrease in testosterone levels. which can cause unwanted side effects such as acne, weight gain and decreased libido. Thus, the addition of testosterone is intended to neutralize these effects while maintaining an exceptionally low sperm count
Progress in the development of male contraception has not proceeded as expected. There were many promising candidates, but all failed. More recently, a clinical trial involving a male contraceptive dose has resulted in serious safety concerns, forcing researchers to complete the study in early 2016.
That said, Wang and his team worked and perfected the gel for nearly a month. decade with small human trials dating back to 2009. And they think they have managed to find the ideal balance between the two hormones in order to create a safe hormonal contraceptive.
"More than 200 men were exposed to drugs and no event occurred that was severe adverse," she told Gizmodo. "But we are going to watch everything very closely."
In addition to tracking the sperm count and the physical health of men, Wang and the entire international team will closely monitor the results obtained by the couple through periodic questionnaires – that would be a break with tradition , according to Wang.
"This is something totally different from what we did before, when you look at the contraceptive studies done by women, they never judge boys," Wang said. ensure that the couple in the study, the couple who uses this contraceptive, is happy to use this method. "
The existence of a male contraceptive would obviously take some of the weight women who need to maintain a routine.Be careful when taking the contraceptive.Bang points out that there is a real need for a better option for men seeking safe and responsible bad, which is more practical than an irreversible surgical procedure, such as a vasectomy
"Condoms are good and protect against badually transmitted diseases. But the failure rate in daily condom use is very high, "she said, citing surveys that show that for a year, 18% of couples who use condoms exclusively still fall pregnant. The gel should be as effective in preventing pregnancy as the hormonal options available to women, and it is expected to achieve 90% or more, depending on compliance with dosing instructions by men. [19659002ItwilltakesometimeforthegeltobeavailableinpharmaciesevenifitworksabadpectedThetestwillbecompletedby2022SinceitisonlypossiblethatofaPhase2bclinicaltrialadditionalstudiesinvolvingthousandsofmenwillberequiredAfterthatregulatoryagenciessuchastheFoodandDrugAdministration(FDAequivalenttoAnvisa)givetheirapproval
sponsored by the US federal government, in conjunction with the Population Council, Wang believes that the final price of the NES / T freeze will not be a deterrent for couples of different income brackets.
"If it works and couples want to use it, will be a medicine reserved for people who can pay the price.
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