A clinical study, funded by the American NIH, was launched last week to examine 240 pairs for two years to assess the effectiveness and safety of a new contraceptive gel. maleThe couples, young and healthy, come from seven countries around the world.
The drug is based on progestogens. A group of hormones that are already used in female contraceptives and have long been known to reduce the burden of sperm to indistinguishable levels of infertility.
Dr. Diana Blee, head of the NICHD contraceptive development program, outlined the benefits of this method:
"Many women can not use hormonal contraception and male contraceptive methods are limited to vasectomy and condoms. Safe, highly effective and reversible male contraception will cover an important public health need. "
NICHD is the National Institutes of Health for Children and Human Development, one of the bodies behind this eventual revolutionary method. The other person in charge is the non-governmental organization called the Population Council. Por now the substance is named NES / T.
According to NIH, the gel form includes the hormone progesterone, known as segesterone acetate, in combination with testosterone. It is actually applied to the back and shoulders and is absorbed through the skin. Progestin "blocks the natural production of testosterone in the testicles, reducing sperm production to low or non-existent levels. "
Even more impressive is that replacement of testosterone maintains normal levels of sexual desire, as well as other functions that depend on the correct level of the hormone in the blood.
The evaluation consists in applying the gel over four to twelve weeks to determine whether volunteers can tolerate the substance and to analyze the severity of the side effects. If no acceptable reduction is observed, the volunteer will continue to use the gel for up to 16 weeks.
Backed by past results, the 240 men in the study will need to apply the gel daily on their arms and shoulders for 20 weeksThis is the time that is expected to reduce sperm load to a minimum. They will then spend one year using another contraceptive method and another six months without taking the drug to check if the sperm count rises again.
Once the production of sperm has decreased to the level of contraception, the phase begins in which the effectiveness of the method will be assessed; this phase will last for 52 weeks. During this time, the couple will rely exclusively on the gel as the only method of contraception.
At the end of the 52 weeks, men will go through periodic assessments for another 24 weeks. If the results are positive, this product can reach the market in a few years.
There was already such a gel, but it was not up to date
For several years, along with the previous project, too Gel that acts as an alternative to reversible vasectomy has been developed, proven to be 100% effective in a recent study.
The substance, that in the first stage it was tested with monkeys, flong-term united and proven as a reliable male contraceptive and sure.
The product is called Vasalgel and has already been tested in rabbits before success with rhesus macaques. Researchers hope that in the future this gel can become an alternative to reversible vasectomy for humans. The study was published in a free access journal, Basic and Clinical Andrology,
Vasalgel is a non-toxic and non-hormonal gel that is sand are injected into the vas deferens, which are the tubes through which the sperm passes from the testicles to the penis. The gel fills the inner cavities of the grooves and acts as a barrier for the sperm. LPrevious studies in rabbits have proven that the procedure is easily reversible, by dissolving the gel with ultrasound.
"Vazallgell promises to be a real alternative to vasectomy, as rabbit studies show that the product is reversible," said lead author Catherine W. W. Worth of the California National Primary Research Center. "Although it is possible to reverse the sectum, it is a technologically challenging procedure and patients often have low levels of fertility after reversal."