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

Authors

Niloufar Ilani
Mara Y. Roth
John K. Amory
Ronald S. Swerdloff
Clint Dart
Stephanie T. Page
William J. Bremner
Régine Sitruk-Ware, Population Council
Narender Kumar, Population Council
Diana Blithe
Christina Wang

Document Type

Article (peer-reviewed)

Publication Date

2012

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.

Recommended Citation

Ilani, Niloufar, Mara Y. Roth, John K. Amory, Ronald S. Swerdloff, Clint Dart, Stephanie T. Page, William J. Bremner, Régine Sitruk-Ware, Narender Kumar, Diana Blithe, and Christina Wang. 2012. "A new combination of testosterone and nestorone transdermal gels for male hormonal contraception," Journal of Clinical Endocrinology and Metabolism 97(10): 3476–3486.

DOI

10.1210/jc.2012-1384

Language

English