A simple and easy-to-use male contraception gel will soon begin a clinical trial for effectiveness, with researchers planning to enroll over 400 couples to see if this approach can achieve the result of preventing pregnancies.
The gel, which would be applied to the shoulders and back of the male, contains two main active principles: testosterone and the progestin compound segesterone acetate. Progestin blocks the natural production of testosterone in the testes, with the goal of reducing the production of sperm to non-existent levels.
The presence of testosterone in the gel is to make sure that the hormone remains at normal levels in the bloodstream. Without it, normal sex drive and other functions may likely be affected. This formulation has been given the name NES/T.
The clinical trial will involve 420 couples and will follow them for up to 23 months. Male volunteers will use the gel daily for four to 12 weeks to determine if the formulation is tolerable and has no unacceptable side effects. This phase can last to up 16 weeks if sperm levels have not declined sufficiently.
Once the desired threshold level for the sperm count is reached, the couple will use the gel as the sole method of contraception. This phase will test if the gel is actually effective at preventing pregnancies. The couples will be followed for a year during this phase.
When they stop using the gel, the male partners will continue to be observed for an additional 24 weeks after the interruption of the contraceptive to quantify the reversibility of the formulation.
“Many women cannot use hormonal contraception and male contraceptive methods are [currently] limited to vasectomy and condoms,” study investigator Dr Diana Blithe chief of National Institute of Child Health and Human Development's (NICHD) Contraceptive Development Program, said in a statement. “A safe, highly effective and reversible method of male contraception would fill an important public health need.”
There are many possible male contraceptives in various different forms currently in development – including another gel, various pills, an injection, and an implant that acts as a switch – though not many that have gone on to the crucial clinical trial stage.
So this is good news that a trial such as this is going forward, and an important step towards equal contraceptive responsibility. The contraceptive pill has been extremely important in changing women’s lives despite many experiencing unpleasant side effects. But since it takes two to procreate, the burden of contraception should be equally shared.