Researchers plan to enroll approximately 420 couples in clinical trial
A clinical trial funded by the National Institutes of Health will evaluate a male contraceptive gel for its ability to prevent pregnancy. The gel formulation was developed by the Population Council and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The Population Council will collaborate with NIH to conduct the study in NICHD’s Contraceptive Clinical Trials Network.
“Many women cannot use hormonal contraception and male contraceptive methods are limited to vasectomy and condoms,” said study investigator Diana Blithe, Ph.D., chief of NICHD’s Contraceptive Development Program. “A safe, highly effective and reversible method of male contraception would fill an important public health need.”
The gel formulation, called NES/T, includes the progestin compound segesterone acetate (brand name Nestorone), in combination with testosterone. It is applied to the back and shoulders and absorbed through the skin. The progestin blocks natural testosterone production in the testes, 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.
Researchers plan to enroll approximately 420 couples into the study. Male volunteers will use the NES/T gel daily for four to 12 weeks to determine whether they tolerate the formulation and to ensure they do not experience unacceptable side effects. If sperm levels have not adequately declined, they will continue to use the formulation for up to 16 weeks. Once their sperm levels have declined to a threshold sufficient for contraception, they will enter the efficacy phase, which will evaluate the ability of the formulation to prevent pregnancy. This phase will last for 52 weeks, and the couple will rely on the male partner’s application of the gel as the sole method of contraception. Males will remain in the study for observation for an additional 24 weeks after they discontinue the formulation.
The study will be conducted at two sites of NICHD’s Contraceptive Clinical Trials Network:
- Los Angeles Biomedical Institute and University of California Los Angeles Medical Center
Christina Wang, M.D., principal investigator
- University of Washington, Seattle
Stephanie Page, M.D., Ph.D., principal investigator
The investigators at the CCTN sites will supervise the following collaborating study sites:
- University of Kansas, Overland Park
Ajay Nangia, MBBS, FACS, collaborating investigator
- University of Edinburgh, Scotland
Richard Anderson, M.D., Ph.D., collaborating investigator
- University of Manchester, United Kingdom
Cheryl Fitzgerald M.D., collaborating investigator
- Karolinska Institute, Stockholm, Sweden
Kristina Gemzell Danielsson, M.D., Ph.D., collaborating investigator
- Kenyatta National Hospital, Nairobi, Kenya
John Kinuthia, MBChB, MMed, collaborating investigator
- Chilean Institute of Reproductive Medicine, Santiago
Gabriela Noe, collaborating investigator
- University of Bologna, Italy
Cristina Meriggiola, M.D., Ph.D., collaborating investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Population Council. Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception. https://clinicaltrials.gov/ct2/show/NCT03452111
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit http://www.nichd.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov