Last week, a US NIH-funded clinical trial began testing 240 pairs over two years to evaluate the effectiveness and safety of the new contraceptive gel. maleCouples, young and healthy, come from seven countries of the world.
The drug is based on progestogen. A group of hormones that are already used in female contraceptives and which have long been known to reduce sperm burden on indistinguishable levels of infertility.
Dr. Diana Blithe, the head of the NICHD contraceptive program, has expressed the benefits of this method:
"Many women can not take hormonal contraceptives and male contraceptive methods are limited to vasectomy and condoms. A safe, highly effective and reversible male contraceptive method would cover an important need for public health. "
NICHD is the National Institute of Child Health and Human Development, one of the institutions for this revolutionary method. The second responsible entity is a non-governmental organization called the Council for the Population. Por now the substance has the name NES / T.
According to NIH, the gel formulation contains the hormone progesterone known as segesterone acetate in combination with testosterone. In fact, it is applied to the back and shoulders and absorbs through the skin. Progestin "blocks the natural production of testosterone in seeds, reduce sperm production to a low or non-existent level. "
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 the application of a gel for 4 to 12 weeks to determine whether volunteers can tolerate this substance and to analyze the severity of the side effects. If there is no acceptable reduction, the volunteer will continue to use the gel for up to 16 weeks.
With support from previous results, 240 male patients will need to apply gel on shoulders and shoulders daily for 20 weeks, This is the estimated time that reduces the sperm load to a minimum. They then spend one year using a different method of contraception and another six months without using the drug to find out that sperm counts are rising again.
As sperm production decreases to the contraceptive level, the phase begins in which the effectiveness of the method will be evaluated; this phase would take 52 weeks. During this time, the couple will rely only on the gel as the only way of contraception.
At the end of 52 weeks, men will undergo periodic evaluations of a further 24 weeks. If the results are positive, this product could be marketed in a few years.
It was already a similar gel, but it was not up to date
Several years along with the previous project as well The gel, which acts as an alternative to reversible vasectomy, has been developed, which proved to be 100 percent effective in a recent study.
Substance, that in the first stage it was tested with monkeys, fhas long been united and has proven to be a reliable male contraceptive and certainly.
The product is called Vasalgel and has been tested in rabbits before success with Rhesus macaques. Scientists hope that in the future this gel can become an alternative to reversible vasectomy in humans. The study was published in Open Access, Basic and clinical andrology,
Vasalgel is a non-toxic and non-hormonal gel which,and injections into the vas deferens, which are the tubes that the sperm get from the testicles to the penis. The gel fills the inner cavity of the canals and acts as a barrier to sperm. LPrevious studies in rabbits have shown that the procedure is easily reversible, by dissolving the gel by ultrasound.
"Vasalgel promises to be a real alternative to vasectomy because rabbit research has shown that the product is reversible," said lead author Catherine VandeVoort of the California National Primary Research Center. "Although it is possible to reverse vasectomy, it is a technically demanding procedure, and patients often have a low fertility rate after a reversal."