Details

Autor(en) / Beteiligte

• 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 L
• Wang, Christina

Titel

A New Combination of Testosterone and Nestorone Transdermal Gels for Male Hormonal Contraception

Ist Teil von

• The journal of clinical endocrinology and metabolism, 2012-10, Vol.97 (10), p.3476-3486

Ort / Verlag

Bethesda, MD: Endocrine Society

Erscheinungsjahr

2012

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• 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.