The National Institutes of Health (NIH) is funding a trial to test whether a male transdural contraceptive gel can prevent pregnancy.
The gel, called NES / T, includes progestin compound seresterone acetate (Nestorone) Plus testosterone. It was developed by the Population Council and Nihs Eunice Kennedy Writer National Institute for Child Health and Human Development (NICHD).
"Many women can not use hormonal contraception and male contraceptive methods are limited to vasectomy and condoms. In certain, highly effective and reversible methods of male contraception would fill an important public health need," study investigator Diana Blithe, PhD, head of Nichd's Contraceptive development program, said in a news release.
The gel / gel is applied to the back and shoulders. The progestin blocks natural testosterone production, reducing sperm production to low or non-insistent levels. The replacement testosterone maintains normal sex drive and other functions that are dependent on adequate blood levels of the hormone, the hoy says.
The amount of gel applied daily is approximately 5 ml in volume (2.5 ml to each shoulder and upper arm per day). The daily gel volume contains about 62 mg of testosterone, which will provide 6 mg of testosterone to the body per day plus 8 mg of sextesterone acetate, which will deliver about 0.8 mg of setterone acetate to the body per day.
The study protocol consists of a conference phase lengthened 4-8 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 only way of contraception.
This is a prospective, phase 2B, open-label, single-arm, multicenter learning. Recruitment is ongoing and the plan is to register about 420 couples in nine clinical sites (about 30-60 couples per site).
The Population Council is working with the NIH to carry out the study in two sites of the Controlling Clinical Trials of NICHD (CCTN): The Los Angeles Biomedical Institute and the University of California, Los Angeles Medical Center, of Washington, Seattle, with chief investigator Stephanie Page , MD, PhD.
The seven Collaborating Teaching 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)
Karolina Institute, Stockholm, Sweden (Kristina Gemzell Danielsson, MD, PhD)
Kennatata National Hospital, Nairobi, Kenya (John Kinuthya, MBCHB)
Chilean Institute of Reproductive Medicine, Santiago (Gabriela Neo)
University of Bologna, Italy (Cristina Meriggiola, MD, PhD)
The primary end date is July 2021.
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