CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
AndroGel 5 Grams +1 moredrug
Likely dose
Not stated in 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/NCT00413244
NCT00413244Phase 3Completed
CompareCT.gov

The Cardiac Benefit of Androgen Replacement in Hypogonadal Males With Coronary Artery Disease Following Successful Percutaneous Coronary Intervention (PCI).

Icahn School of Medicine at Mount Sinai·interventional·Posted Dec 19, 2006·Updated Jan 5, 2017

In Brief

A Phase 3 clinical trial evaluating AndroGel 5 Grams and Placebo for Coronary Artery Disease. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in males with coronary artery disease (CAD) following successful percutaneous coronary intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2006
Enrollment StartJan 1, 2007
Primary CompletionJan 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 19.5 years ago

Interventions

AndroGel 5 Gramsdrug

Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo. Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.

Placebodrug

Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo. Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.