D. WiehleRonald, K. FontenotGregory, S. WillettMichael
Nov 17, 2014
Citations
1
Influential Citations
8
Citations
Quality indicators
Journal
Journal of Men's Health
Abstract
Abstract Background: It is not unusual for men over 60 years of age to have serum testosterone levels below the lower limits of younger men, prompting a diagnosis of hypogonadism. This study evaluated safety, efficacy, and pharmacokinetics of oral enclomiphene citrate as an alternative to currently available androgen replacement therapies. Methods: Fifty-two subjects were randomized to oral enclomiphene citrate (12.5 mg, 25 mg, or 50 mg), topical testosterone gel (5 g) or oral placebo daily for 14 days. Pharmacodynamic profiles of total testosterone (TT) were obtained on day 1 and day 14 after dosing. Subjects were assessed in a follow-up visit 7–10 days after the final dose. Additional subjects were rescreened and added for a 10-g dose cohort. Results: After 14 days, there was a significant, dose-dependent rise in TT across all doses of enclomiphene citrate and topical testosterone, but not placebo. Supraphysiologic levels of TT were observed in topical testosterone-treated subjects, whereas TT levels we...