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Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects

NCT01813201 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-12-13

No results posted yet for this study

Summary

The purpose of this clinical trial is to determine whether intermittent administration of testosterone against placebo is associated with a reduction of mortality and heart failure hospitalizations at 1 year, in male patients with advanced heart failure and testosterone deficiency.

Conditions

Interventions

DRUG

Testosterone undecanoate

Testosterone undecanoate intramuscular long-acting, 1000 mg/dose, administered at inclusion and every 12 weeks for 9 months (4 dose) (testosterone group) against the administration of placebo (saline isotonic solution).

DRUG

Saline isotonic solution

Saline isotonic solution (placebo)intramuscular,administered at inclusion and every 12 weeks for 9 months (4 dose)

Sponsors & Collaborators

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Principal Investigators

  • Domingo A Pascual-Figal, MD, PhD · Hospital Universitario Virgen Arrixaca

  • Antoni Bayes-Genis, MD, PhD · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT01813201 on ClinicalTrials.gov