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

NCT00434824 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2015-04-16

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2004-07-31
Completion
2004-07-31

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00434824 on ClinicalTrials.gov