Tuesday , October 4 2022

NIH Silver Trial of Human Birth Control Gel in progress



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National Health Institutions (NIH) fund a trial to prove that transnational contraceptive gel can prevent pregnancy.

The gel, called NES / T, contains the progestin composite hagesterone acetate (Nestorone) together with testosterone. I was developed by the Population Council and National Institute for Human Health and Development (NICHD) Eunice Kennedy Shriver NIH.

"Many women can not use hormonal contraception and male contraception is limited to vasectomy and condoms. A safe, highly effective and abusive method of contraception of men would fill an important public health need," Diana Blithe, PhD study researcher, The main development of contraceptive NICHD Program, in a news release.

The NES / T gel is used to the back and shoulder. The progestin blocks the production of natural testosterone, reducing the production of sperm to low levels or does not exist. The new testosterone carries out the normal sex campaign and other functions that depend on the adequate blood levels of the hormone, which the NIH explains.

The amount of gel applied daily is about 5 ml of volume (2.5 mL per shoulder and upper arm per day). This daily gel volume contains about 62 mg of testosterone that will provide 6 mg of testosterone to the body per day together with 8 mg of segesterone acetate that will provide approximately 0.8 mg of acetate to a cassetter to & The body of the day.

The study protocol includes a screening period for 4 to 8 weeks, estimating a disposal phase of up to 20 weeks, maintenance / 52-week maintenance period (prevention of pregnancy), and a 24 week recovery period ( estimated). During pregnancy prevention, the couple will depend on the application of the gel to a male partner as the sole contraception.

This is a possible study, phase 2b, open labeling, one-arm, multi-enterprise. Recruitment is ongoing and the scheme is to register around 420 couples in nine clinical sites (around 30 to 60 couples on each site).

The Population Council is working with the NIH to conduct the study in two sites from the NICHD Genetic Clinical Trials Network (CCTN): Los Angeles Biomedical Institute and the California Los Angeles Medical Center, with the main researcher Christina Wang, MD, and University of Washington, Seattle, with the leading researcher Stephanie Page, MD, PhD.

The seven collaborative study sites (and researchers) are:

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

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

  • Manchester University, UK (Cheryl Fitzgerald, MD)

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

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

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

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

The primary specified completion date of the projected study is July 2021.

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