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- Title
Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men.
- Authors
Mahabadi, Vahid; Amory, John K; Swerdloff, Ronald S; Bremner, William J; Page, Stephanie T; Sitruk-Ware, Regine; Christensen, Peter D; Kumar, Narender; Tsong, Yun-Yen; Blithe, Diana; Wang, Christina
- Abstract
<bold>Context: </bold>Testosterone (T) plus progestin combinations are the most promising hormonal male contraceptives. Nestorone (NES), a progestin without estrogenic or androgenic activity, when combined with T may be an excellent candidate for male contraception.<bold>Objective: </bold>Our objective was to determine the effect of transdermal NES gel alone or with T gel on gonadotropin suppression.<bold>Design and Setting: </bold>The randomized, unblinded clinical trial was conducted at two academic medical centers.<bold>Participants: </bold>A total of 140 healthy male volunteers participated.<bold>Interventions: </bold>One hundred subjects were randomized initially (20 per group) to apply NES gel 2 or 4 mg, T gel 10 g, or T gel 10 g plus NES gel 2 or 4 mg daily for 20 d. Because only about half of the subjects in T plus NES 4 mg group suppressed serum gonadotropins to 0.5 IU/liter or less (suboptimal suppression), two additional groups of 20 men were randomized to apply daily T gel 10 g plus NES gel 6 or 8 mg.<bold>Main Outcome Variable: </bold>Suppression of serum LH and FSH concentrations to 0.5 IU/liter or less after treatment was the main outcome variable.<bold>Results: </bold>A total of 119 subjects were compliant with gel applications with few study-related adverse events. NES alone reduced gonadotropins significantly but less than T gel alone. Combined T gel 10g plus NES gel 6 or 8 mg suppressed both serum gonadotropins to 0.5 IU/liter or less in significantly more men than either gel alone.<bold>Conclusion: </bold>Transdermal NES gel alone had gonadotropin suppression activity. Combined transdermal NES (6 or 8 mg) plus T gel demonstrated safe and effective suppression of gonadotropins, justifying a longer-term study of this combination for suppression of spermatogenesis.
- Subjects
GLYCOPROTEIN analysis; BIOCHEMISTRY; COMBINATION drug therapy; COMPARATIVE studies; CONTRACEPTION; DRUG administration; PHARMACEUTICAL gels; GONADOTROPIN; MALE contraceptives; PHENOMENOLOGY; RESEARCH methodology; MEDICAL cooperation; SYNTHETIC progestagens; RESEARCH; RESEARCH funding; STEROIDS; TESTOSTERONE; TRANSDERMAL medication; EVALUATION research; RANDOMIZED controlled trials; PHARMACODYNAMICS
- Publication
Journal of Clinical Endocrinology & Metabolism, 2009, Vol 94, Issue 7, p2313
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2008-2604