The US National Institutes of Health (NIH) has provided funding for a clinical trial to examine the effectiveness of male contraceptive skin gel NES/T.
Non-governmental organisation Population Council and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) have jointly developed NES/T.
The trial will be conducted at two NICHD Contraceptive Clinical Trials Network sites in the US and researchers intend to enroll around 420 couples.
NICHD Contraceptive Development Programme chief and the trial’s investigator Diana Blithe said: “Many women cannot use hormonal contraception and male contraceptive methods are limited to vasectomy and condoms.
“A safe, highly effective and reversible method of male contraception would fill an important public health need.”
The trial will see male participants using NES/T daily over a period of four to 12 weeks to assess tolerance to the formulation and to ensure there an no unacceptable side effects.
If sperm levels do not decline adequately, participants will continue to use the gel for up to 16 weeks.
Following the declining of the sperm levels to an amount required for contraception, the trial will enter the efficacy phase and assess the ability of the gel to prevent pregnancy.
The efficacy phase will be conducted for 52 weeks, during which the couple will use the NES/T gel as the only method of contraception.
Researchers will observe the males for an additional 24 weeks after they discontinue the gel.
NES/T features a combination of the progestin compound segesterone acetate (brand name Nestorone) and testosterone. The formulation is applied to the back and shoulders for the skin to absorb.