Designed contraceptive gel for the man instead of pill for the woman

Study to check the effectiveness of the contraceptive gel for the man

Currently, men who want to take the contraception into their own hands, only the choice between condoms and a vasectomy. Hormonal contraceptive methods for men have not yet been approved. This could change soon, because a large-scale study to check the efficacy of a hormone gel for male birth control is due to start next spring. Will the new gel prevail for contraception?

Already over a decade of work and testing, US researchers invested in the novel method of contraception for men. The gel is applied to the upper body of the man and is intended to inhibit sperm production. 400 pairs are to test the gel. The approximately four-year clinical trial is scheduled to start in April 2018 and is the largest project to date in the US for the testing of hormonal contraceptive methods for men.

How does the new contraceptive gel work??

Subjects to the study rub around half a teaspoon of the gel on their upper arms and shoulders every day. The gel should dry within one minute. The ingredients of the gel include the two synthetic hormones progestin and testosterone. On the one hand, the progestin should prevent the testes from generating enough testosterone for normal sperm production. On the other hand, synthetic testosterone is needed to remedy the hormone imbalance caused by progestin. Synthetic testosterone does not cause sperm production in the body. According to Régine Sitruk-Ware, a Scientist at the Population Council, the gel can inhibit sperm production for approximately 72 hours. So there would be some tolerance if users forget a dose.

How is the gel tested??

For at least four months, the subjects of the study should use the gel. The respective partner of the participating men should also use a form of contraception for women. The researchers control sperm production at regular intervals. According to Diana Blithe, Program Director for Contraceptive Development at the US National Institute of Health and Human Development, sperm production must drop to less than one million per milliliter to effectively prevent pregnancy. Only when the number of sperm has dropped far enough, the woman could stop the contraception. Afterwards, the gel should be the only contraceptive method of the couple for another year.

First study already successful

In a previous six-month study, the method had already proven effective. At this time, however, two different gels were used, which had to be applied to different parts of the body. The Blithe team has therefore worked on new formulas for the hormones to bring them together in a gel. According to Blithe, the gel works better than hormone pills because laboratory-made testosterone is rapidly broken down by the body. In gel form, it is absorbed by the skin and stays longer in the bloodstream.

Previous hormonal preparations for men led to side effects

From 2008 to 2012, a large study on hormonal contraception for men took place in Europe, published in The Journal of Clinical Endocrinology & Metabolism. Participants were given an injection of a hormone drug every two months. The drug suppressed sperm production. Although the partners of the subjects were not pregnant, but the men suffered from severe side effects and mood swings.

Men will use the gel too?

According to Technology Review magazine, pharmaceutical companies have not shown much interest in male contraception in the past. Clinical trials would take years and be enormously expensive, so they are a risky endeavor, especially as there are many contraceptives for women. "This is about gender equality," says Sitruk-Ware. "Men want to be able to control their own fertility and not be forced to paternity," the researcher continues. The attitude of men towards contraception differs from country to country. However, according to a global study from 2010, at least 25 percent of men would consider taking a hormonal contraceptive. "I'm very confident that the gel will be effective if men apply it daily and use it correctly," says Stephanie Page, a professor of medicine at the University of Washington and lead researcher in the study. Even if the tests are successful, it would still take a few years for the gel to be publicly available, according to Blithe. (Fp)