A New Combination of Testosterone and Nestorone Transdermal Gels for Male Hormonal Contraception
Year: 2012
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: CONTEXT: Combinations of testosterone (T) and nestorone (NES; a nonandrogenic progestin) transdermal gels may suppress spermatogenesis and prove appealing to men for contraception. OBJECTIVE: The objective of the study was to determine the effectiveness of T gel alone or combined with NES gel in suppressing spermatogenesis. DESIGN AND SETTING: This was a randomized, double-blind, comparator clinical trial conducted at two academic medical centers. PARTICIPANTS: Ninety-nine healthy male volunteers participated in the study. INTERVENTIONS: Volunteers were randomized to one of three treatment groups applying daily transdermal gels (group 1: T gel 10 g+NES 0 mg/placebo gel; group 2: T gel 10 g+NES gel 8 mg; group 3: T gel 10 g+NES gel 12 mg). MAIN OUTCOME VARIABLE: The main outcome variable of the study was the percentage of men whose sperm concentration was suppressed to 1 million/ml or less by 20-24 wk of treatment. RESULTS: Efficacy data analyses were performed on 56 subjects who adhered to the protocol and completed at least 20 wk of treatment. The percentage of men whose sperm concentration was 1 million/ml or less was significantly higher for T+NES 8 mg (89%, P<0.0001) and T+NES 12 mg (88%, P=0.0002) compared with T+NES 0 mg group (23%). The median serum total and free T concentrations in all groups were maintained within the adult male range throughout the treatment period. Adverse effects were minimal in all groups. CONCLUSION: A combination of daily NES+T gels suppressed sperm concentration to 1 million/ml or less in 88.5% of men, with minimal adverse effects, and may be further studied as a male transdermal hormonal contraceptive.
DOI: 10.1210/jc.2012-1384
Institutions: University of California, Los Angeles, The Lundquist Institute, Harbor–UCLA Medical Center, University of Washington, Los Angeles Medical Center, Health Decisions (United States), Population Council, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: University of Washington, National Institutes of Health, University of California, Los Angeles, U.S. Public Health Service, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development, National Center for Research Resources, National Center for Advancing Translational Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: G1463467731, UCLA Clinical and Translational Science Institute, G1738805643, G2076493829, G2408971297, G2663518188, UCLA Clinical and Translational Science Institute, G3549828030, Endocrinology, Metabolism and Nutrition Training Grant, G3838971607, G3846476606, G5950577451, Men's Reproductive Health Research at the University of Washington, General Clinical Research Center, G9000311773, G988347082
OpenAlex ID: W2038858525