Male Birth Control Gel to Go Into Trials
Source: National Institute of Child Health and Human Development
Summary: The first-ever contraceptive transdermal gel for male hormonal contraception is to be tested next year. It’s expected to deliver hormones more effectively than injections or pills.
Currently, the only available forms of contraception to men are condoms and vasectomies (a surgical procedure for male sterilization). Though researchers have sought contraception options similar to those for women, such attempts have met with failure due to unwanted side effects. A research team at the US National Institute of Child Health and Human Development has announced that it has developed a first-ever contraceptive transdermal gel for male hormonal contraception that will be put into trials next year April. In this new effort, the researchers claim they have found a solution to the problem, a dual chemical gel that can be applied to the arms and shoulders every day without causing mood swings or other side effects. The detailing of the gel was published in the journal Journal of Clinical Endocrinology & Metabolism.
Starting in April, the clinical trial will run for about 4 years and will be the largest effort in the U.S. to test a hormonal form of contraception for men. The trials will involve more than 400 couples in the U.S., Italy, Chile, Kenya, the U.K. and Sweden. The gel is made up of two synthetic hormone progestin (Nesterone) and testosterone. Progestin prevents testosterone production, which the body needs to produce sperm cells. The synthetic testosterone replaces the lost natural testosterone to restore hormonal balance – but in way that does not result in sperm production.
About a half-teaspoon’s worth the gel is applied to the upper arms and shoulders but not the genitals to have the maximum skin coverage. The active ingredients make their way slowly into the bloodstream. Application of the gel will cause a drop in sperm production for approximately 72 hours. Researchers report that the method works much better than a pill because it is not cleared from the body so quickly. They are confident that if men put the gel on every day and apply it correctly, it will be effective.
Program Director, Diana Blithe said, Men will use the gel for at least four months while their partners also use some form of female contraception. Researchers will monitor the men’s sperm levels, which need to drop to less than one million per milliliter to effectively prevent pregnancy”, “Once the sperm count is low enough, the women will go off their birth control. The couples will then use the contraceptive gel as their only form of daily birth control for a year”.
Niloufar Ilani et al, “A New Combination of Testosterone and Nestorone Transdermal Gels for Male Hormonal Contraception”, The Journal of Clinical Endocrinology & Metabolism (2012). DOI: 10.1210/jc.2012-1384
Hermann M. Behre et al, “Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men”, The Journal of Clinical Endocrinology & Metabolism (2016). DOI: 10.1210/jc.2016-2141