Abstract
A new combination of testosterone and nestorone transdermal gels for male hormonal contraception (HTML)
Ilani,Niloufar; Roth,Mara Y.; Amory,John K.; Swerdloff,Ronald S.; Dart,Clint; Page,Stephanie T.; Bremner,William J.; Sitruk-Ware,Regine; Kumar,Narender; Blithe,Diana; Wang,Christina
Journal of Clinical Endocrinology and Metabolism 97(10): 3476-3486
Publication date: 2012
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.
What's New
For 60 years, the Population Council has changed the way the world thinks about important health and development issues. Explore an interactive timeline of the Council's history, learn more about some of our key contributions, and watch a short video about why your support is so important to us.
Get Involved
- Make a contribution to the Population Council
- Honor a loved one with a gift in his or her name
- Sign up to receive e-mail announcements








