A new combination of testosterone and nestorone transdermal gels for male hormonal contraception.

Author(s): Ilani N, Roth MY, Amory JK, Swerdloff RS, Dart C, Page ST, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Wang C.

Affiliation(s): Department of Medicine, Harbor-University of California, Los Angeles, Medical Center and Los Angeles Biomedical Research Institute, 1000 West Carson Street, Torrance, California 90509, USA.

Publication date & source: 2012, J Clin Endocrinol Metab. , 97(10):3476-86

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.