CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
Testosterone undecanoate +1 moredrug
Likely dose
Testosterone undecanoate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01813201
NCT01813201Phase 4Completed

A Randomized and Double-blind Study to Evaluate the Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·interventional·Posted Mar 18, 2013·Updated Dec 13, 2017

In Brief

A Phase 4 clinical trial evaluating Testosterone undecanoate and Saline isotonic solution for Heart Failure. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesSpain

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2013
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.3 years ago

Interventions

Testosterone undecanoatedrug

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).

Saline isotonic solutiondrug

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