A new combination of testosterone and nestorone transdermal gels for male hormonal contraception.
Open Access
- 1 October 2012
- journal article
- research article
- Published by The Endocrine Society in Journal of Clinical Endocrinology & Metabolism
- Vol. 97 (10), 3476-86
- https://doi.org/10.1210/jc.2012-1384
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.Keywords
This publication has 40 references indexed in Scilit:
- The use of newer progestins for contraceptionContraception, 2010
- Combined Transdermal Testosterone Gel and the Progestin Nestorone Suppresses Serum Gonadotropins in MenJournal of Clinical Endocrinology & Metabolism, 2009
- Simultaneous Measurement of Serum Testosterone and Dihydrotestosterone by Liquid Chromatography–Tandem Mass SpectrometryClinical Chemistry, 2008
- Discontinuation and resumption of contraceptive use: results from the 2002 National Survey of Family GrowthContraception, 2008
- Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitusPublished by Wiley ,2007
- 10th Summit Meeting consensus: recommendations for regulatory approval for hormonal male contraceptionContraception, 2007
- Pharmacokinetics of Testosterone Undecanoate Injected Alone or in Combination With Norethisterone Enanthate in Healthy MenJournal of Andrology, 2006
- Male hormonal contraceptionAmerican Journal of Obstetrics and Gynecology, 2004
- Intramuscular testosterone undecanoate with or without oral levonorgestrel: a randomized placebo‐controlled feasability study for male contraceptionClinical Endocrinology, 2000
- Contraception with subcutaneous capsules containing ST-1435. Pituitary and ovarian function and plasma levels of ST-1435Contraception, 1981