NIH-Funded Trial of Male Birth Control Gel Underway

Megan Brooks

December 03, 2018

The National Institutes of Health (NIH) is funding a trial to test whether a male transdermal contraceptive gel can prevent pregnancy.

The gel, called NES/T, includes the progestin compound segesterone acetate (Nestorone) plus testosterone. It was developed by the Population Council and NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

"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," study investigator Diana Blithe, PhD, chief of NICHD's Contraceptive Development Program, said in a news release.  

The NES/T gel is applied to the back and shoulders. The progestin blocks natural testosterone production, reducing sperm production to low or nonexistent levels. The replacement testosterone maintains normal sex drive and other functions that are dependent on adequate blood levels of the hormone, the NIH explains.

The amount of gel applied daily is roughly 5 mL in volume (2.5 mL to each shoulder and upper arm per day). This daily gel volume contains about 62 mg of testosterone that will deliver 6 mg of testosterone to the body per day plus 8 mg of segesterone acetate that will deliver about 0.8 mg segesterone acetate to the body per day.

The study protocol consists of a screening phase lasting 4 to 8 weeks, a suppression phase estimated up to 20 weeks, a 52-week maintenance/efficacy phase (pregnancy prevention), and a 24-week (estimated) recovery phase. During the pregnancy prevention phase, the couple will rely on the male partner's application of the gel as the sole method of contraception.

This is a prospective, phase 2b, open-label, single-arm, multicenter study. Recruitment is ongoing and the plan is to enroll about 420 couples at nine clinical sites (about 30 to 60 couples per site).

The Population Council is collaborating with the NIH to conduct the study at two sites of the NICHD's Contraceptive Clinical Trials Network (CCTN): the Los Angeles Biomedical Institute and University of California Los Angeles Medical Center, with principal investigator Christina Wang, MD, and University of Washington, Seattle, with principal investigator Stephanie Page, MD, PhD. 

The seven collaborating study sites (and investigators) are:

  • University of Kansas, Overland Park (Ajay Nangia, MBBS)

  • University of Edinburgh, Scotland, UK (Richard Anderson, MD, PhD)

  • University of Manchester, UK (Cheryl Fitzgerald, MD)

  • Karolinska Institute, Stockholm, Sweden (Kristina Gemzell Danielsson, MD, PhD)

  • Kenyatta National Hospital, Nairobi, Kenya (John Kinuthia, MBChB)

  • Chilean Institute of Reproductive Medicine, Santiago (Gabriela Noe)

  • University of Bologna, Italy (Cristina Meriggiola, MD, PhD)

The study's anticipated primary endpoint completion date is July 2021.

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