SEATTLE (CIRCA via KOMO) — A revolutionary new male contraceptive gel that could prevent millions of unintended pregnancies worldwide is about to undergo trials at the University of Washington's School of Medicine.
The university is now enrolling couples for the clinical trials. It is one of three sites testing the safety and effectiveness of the newly developed contraceptive gel for men, which is designed to be applied to the upper arms and shoulders daily and absorbed through the skin.
“The really groundbreaking thing here is, there have been other studies of male hormonal contraceptive products, but this is the first self-delivered method,” said Dr. Stephanie Page, professor of medicine at the UW School of Medicine.
The gel, comprised of segesterone acetate and testosterone, is designed to decrease a man’s sperm production without reducing his sexual drive or enjoyment. Its effects are reversible once its use is stopped.
"The potential of this new gel is huge. There is a misperception that men are not interested in, or are even afraid of, tools to control their own fertility. We know that’s not the case."
"The potential of this new gel is huge,” said William Bremner, professor of medicine at the UW School of Medicine and trial director in Seattle. "There is a misperception that men are not interested in, or are even afraid of, tools to control their own fertility. We know that’s not the case."
Previous multinational surveys have shown that more than half of men say they would use a male contraceptive if it is reversible and uncomplicated. Proving the new gel's effectiveness and acceptability is essential to overcoming misperceptions that men aren’t interested in new contraceptive options.
The trial is first launching in Seattle, Los Angeles and Kansas City, Kan., and later will include sites in Chile, England, Italy, Kenya, Scotland and Sweden.
Each year, 85 million pregnancies — or 40 percent of all pregnancies worldwide — are unplanned, contributing to a higher incidence of adverse health outcomes for women and infants. Apart from condom use, withdrawal during sex and vasectomy, no other contraceptive options have existed for men — until development of the gel.
More than 400 couples are anticipated to enroll in the first test of the gel product, known as Nestorone or NES/T, to see how effectively it prevents pregnancy.
"We have been developing this product for more than a decade," said Diana Blithe of the National Institute of Child Health and Human Development. "We are hopeful that the NES/T gel study will demonstrate effectiveness of a male method for use by couples. A successful result may lead to additional scientific discovery around contraceptive products for men."
Men and their female partners will be active participants in the test. 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 eight 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 trial will also test the acceptability of the daily gel application as a contraceptive among the participating couples — a critical measure for real-world use.
"Expanding male contraceptive options could help make family planning more of a shared responsibility between women and men," said Regine Sitruk-Ware, a co-director of the trial. "Safe, effective and reversible tools for men to control their own fertility gives new meaning and significance to the term 'family planning.'"
Results from the trial are expected in 2022 and will help determine whether the NES/T gel should be evaluated in a separate, larger-scale trial, with the aim of obtaining approval from the U.S. Food and Drug Administration to market the product as a male contraceptive.
Interested couples can find researchers' contact information and selection criteria here.