This is the html version of the file http://www.futureofmalecontraception.com/Documents/Speaker%20Abstracts/Abstract_C%20Wang.doc
Google automatically generates html versions of documents as we crawl the web.
Wang, Christina
Transdermal Nestorone and Testosterone Gels Suppresses Gonadotropins in Healthy Men
Christina Wang, John Amory, Vahid Mahabadi, Stephanie Page, Peter Christenson, Regine Sitruk-Ware, Narender Kumar, YY Tsong, Diana Blithe, William Bremner and Ronald Swerdloff
Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA90509 (CW, VM, PC, RS); Divisions of Endocrinology and General Internal Medicine, Department of Medicine, University of Washington, Seattle, WA 98185 JA, SP, WB); Center for Biomedical Research, Population Council, New York, NY 10021 (RSW, NK, YYT); and CRHB, Center for Population Research, NICHD, NIH (DB).
Introduction: Nestorone (Nes) is a progestin without estrogenic or androgenic activity. To investigate whether Nes has any effect on suppression of gonadotropins and whether it has any additive effect when administered with testosterone (T), we recruited healthy men to a proof of concept study.
Study design: The 140 participants applied one or both these agents daily as a transdermal gel for 20 days. The transdermal route was chosen because of ease of use and delivery of the steroids at steady levels. The subjects were randomized initially into groups of 20 to receive 10 gel T gel; 2 mg Nes gel; 4 mg Nes gel; 10 g T gel + 2mg Nes gel; and 10 g T gel + 4mg Nes gel. Before and on day21, 5 blood samples were drawn to measure serum LH and FSH levels. As the suppression of gonadotropins to very low levels occurred only in smaller than anticipated proportion of subjects, two additional group of 20 men were enrolled to receive 10 g T gel + 6 mg Nes gel and 10 g T gel + 8 mg Nes gel.
Results: Data were presented from 119 subjects who were considered compliant with the application of the gels based on preset criteria. Nes alone suppressed gonadotropin levels significantly but not to very low levels. As shown in the table below T gel 10g plus Nes gel 6 or 8 mg suppressed both serum LH and FSH to very low levels. Prior studies suggest that suppression of both gonadotropins to such low levels is compatible with inhibition of spermatogenesis if the gels would have been applied for longer periods. There were no significant adverse events or changes in blood counts and chemistry.
Percent Subjects with Suppression of Gonadotropins with daily application Testosterone and Nestorone Gel for 20 days (Compliant subjects with detectable Nestorone on day21)
Conclusion: We conclude that this proof of concept study showed that Nes gel had some moderate gonadotropin suppressive activity, Nes when applied at 8mg plus T gel 10 g per day suppressed gonadotropins severely. A study to assess the suppression of spermatogenesis with this combination of Nes and T gel is warranted,