New York: A groundbreaking trial to test the safety and efficacy of new male contraceptive gel that could prevent millions of unwanted pregnancies is about to undergo at the University of Washington’s School of Medicine in Seattle. If the results are positive it will soon create a revolution in the contraceptive market.
The safety and efficacy of the male contraceptive gel, developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), will be evaluated in a clinical trial to determine its ability to prevent pregnancy. Three trial sites in the U.S. are now enrolling couples.
The gel being tested is composed of Nestorone® (segesterone acetate), a progestin hormone used for female contraception, and testosterone. NES/T is a novel, reversible contraceptive for men designed to be absorbed through the skin on the upper arms and shoulders.
In a similar study published in journal Basic and Clinical Andrology, Medical Dialogues has earlier reported that a contraceptive gel called Vasalgel™has provided long-term and reliable contraception in male rhesus monkeys and the product which was trialed in rabbits in 2016, has the potential to be a reversible alternative to vasectomy.
Men will apply the gel once every day. Once the man’s sperm count reaches an appropriate level to prevent pregnancy—a process anticipated to take 8 to 16 weeks, the couple will be informed that they should begin to use the gel as their only form of contraception for one year. During this phase, the man’s sperm count will be checked regularly to help minimize the possibility of pregnancy.
The NES/T gel is a transparent gel designed to decrease a man’s sperm production without reducing his sexual drive or enjoyment. The trial will also test the acceptability of the daily gel application as a contraceptive among the participating couples.
More than 400 couples are anticipated to enroll in the trial. Once the male partner has been shown to have responded to the gel, the couple agrees to use the product as their contraceptive method for one full year. The trial is recruiting couples throughout the NICHD’s Contraceptive Clinical Trials Network (CCTN). It is first launching at sites in Los Angeles, Seattle, and Kansas City in the US, and later will include sites in Chile, England, Italy, Kenya, Scotland, and Sweden.
“The success of a reversible contraceptive for men requires an approach that reduces the production of sperm without impacting a man’s testosterone levels or ability to produce sperm at a later date,” said Christina Wang, MD, Los Angeles Biomedical Research Institute lead researcher and a principal investigator of the trial. “The challenge is achieving the right combination of Nestorone and testosterone at the right time.”
Results from the NES/T gel trial are expected in 2022 and will help determine whether it should be evaluated in a separate, larger-scale Phase III contraceptive efficacy clinical trial, with the aim of obtaining approval from the U.S. Food and Drug Administration to market the product as a male contraceptive.
Use of contraception is a common practice adopted by humans since decades to prevent pregnancy, beginning with the withdrawal method to a variety of techniques, medications, and devices. However technological advancement in contraception has conventionally focused on the woman as there are various alternatives available in the market such as many kinds of hormonal, barrier, intrauterine device and emergency contraceptive methods leaving men with only two main options: either using condoms or undergoing a vasectomy.