drugset / Trial / NCT00434824

Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

NCT00434824

Phase 2 Completed 322 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone. Specifically, we have studied the effects on: * symptoms suggestive of low testosterone levels * blood testosterone and other hormone levels * bone mass * muscle mass and fat mass * muscle strength * prostate * lipids, hematocrit

Timeline

Start
2001-11
Primary completion
2004-07
Completion
2004-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Testosterone Undecanoate Small molecule 80 mg Oral
Comparator Testosterone Undecanoate Small molecule 160 mg Oral
Comparator Testosterone Undecanoate Small molecule 240 mg Oral

Indications