Researchers from the University of Utah have begun Phase 2 of clinical trials for a new type of birth control. This novel birth control is a contraceptive gel for men, creating a shift in dynamics in terms of birth control responsibility.
The clinical trials are part of the ongoing Study of the Daily Application of Nestorone® (NES) and Testosterone (T). The two hormones form a combination gel for male contraception. With this new contraceptive, a man's sperm production decreases significantly without affecting sex drive. With an additional option for contraception in men, women who usually bear the burden of birth control are reduced.
Expansion of Male Options
The new hormonal contraceptive gel has been developed by Eunice Kennedy Shriver of the National Institutes of Health (NIH), the National Institute of Child Health and Human Development, and the Population Council. This expands the choices of men as their options to help reduce the pregnancy of their partners are limited.
Women have traditionally borne the burden of contraception since they have to live with the consequences of pregnancy. According to the principal investigator of the clinical trials, David Turok, it is an opportunity for men to take a more active role in developing new ways of contraception.
According to the contraceptive gel clinical trials web page, researchers are recruiting 12 couples to participate in the second phase of their two-year study. The said trials are part of nationwide research that the NIH support.
Combination Hormones
At present, men have few options to reduce pregnancy risks, such as condoms, vasectomy, withdrawal, or abstinence. Natural testosterone production is blocked with the newly developed gel while maintaining sex drive and other biological functions dependent on testosterone.
How does the gel work? The gel contains synthetic progesterone called Nestorone®, which reduces natural sperm production by blocking testosterone production. In addition, the gel also contains replacement testosterone that will help the man maintain his sexual drive.
Goals of the Clinical Trials
Apart from effectiveness, researchers also aim to assess how men diligently apply the gel daily with the ongoing trials. Eligible couples for the second phase must be healthy, and men must be within 18 to 50 years old, while women must be aged 18 to 34 years old, and couples must have no fertility issues. Couples must be sexually active and mutually monogamous for at least a year. In addition, women must have regular menstrual cycles.
According to the University of Utah Health, in the first four to six months of the trials, the couples must use other forms of contraception because it takes about that length of time for the said gel to reduce a man's sperm count. When the sperm count of males goes to a level that is enough to prevent pregnancy, the couples will use the contraceptive gel as their only form of birth control for a year. Researchers will monitor both the testosterone levels and sperm count of participating males throughout the study.
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