NCT00434824

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

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypogonadism
• Androgens

Interventions

Type	Name	Description
DRUG	Oral testosterone undecanoate (Andriol)	treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
DRUG	Placebo	treatment for 12 months with placebo in divided doses

Timeline

• Start date: 2001-11-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2007-02-13
• Last updated: 2015-04-16