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Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

NCT00555087 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-11-07

No results posted yet for this study

Summary

The main objective of this study is to evaluate the response of erectile dysfunction in hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.

Secondary Study Objectives

* To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid profile, renal-hepatic profile and glycemia, and control by means of a rectal digital examination.
* To Determinate physiologic reconstitution in patients under treatment by means of total and free testosterone dosage.

Conditions

Interventions

DRUG

Testosterone Undecanoate and/or PDE-5

Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Hospital Santa Fe

    lead OTHER

Principal Investigators

  • Jorge Jaspersen, MD · H Santa Fe

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Completion
2008-01-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases
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 NCT00555087 on ClinicalTrials.gov