The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery

NCT00413244 | Completed Phase 3 Results DMC

• 1 other identifier: GCO 06-1081
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Hypogonadal; coronary artery disease; percutaneous coronary intervention (PCI)

Outcome Measures

Primary Outcomes (2)

• Cardiac Stress Test: Time to ST Depression

  Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.

  at 6 months

• Cardiac Stress Testing: Exercise Capacity

  Exercise capacity was measured using exercise time.

  At 1 month, 3 months, and 6 months

Secondary Outcomes (10)

• Seattle Angina Questionnaire (SAQ)

  up to 6 months

• Reactive Hyperemia Index

  6 months

• International Prostate Symptom Score (IPSS)

  6 months

• Metabolic Equivalents of Task (METS)

  6 months

• Aging Male Symptoms (AMS)

  At baseline, 1 month, 3 months, and 6 months

Study Arms (2)

Androgel treatment

EXPERIMENTAL

Androgel 5 grams Androgel treatment - 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.

Drug: AndroGel 5 Grams

Placebo

PLACEBO COMPARATOR

Placebo - 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.

Drug: Placebo

Interventions

AndroGel 5 Grams DRUG

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.

Androgel treatment

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male patients with coronary artery disease (CAD) (one to three vessel diseased).
• Stable cardiac status at least 3 months after percutaneous coronary intervention (PCI).
• No change in cardiac medications for 4 weeks prior to enrollment.
• Testosterone \< 300 ng/dl or free testosterone \< 5.0 ng/dl or bioavailable testosterone \< 150 ng/dl.
• Sex Hormone Binding Globulin (SHBG) \< 7nmol/liter and Free Testosterone \< 50pg/dl
• Prostate Specific Antigen (PSA) \< 2.5 ng/mL or 2.6-3.7ng/mL with a negative prostate biopsy within the last 6 months and pathology report available for investigator's review.
• Subgroup of diabetics with well to moderately controlled diabetes (defined by a HgbA1c of \< 9mg/dL.

You may not qualify if:

• Hematocrit greater than 50%.
• Severe hypertension (exhibit systolic blood pressure \>180mmHg and diastolic blood pressure \>110 mmHg at baseline visit or a have a history of malignant hypertension.
• Significant cardiac arrhythmia (supraventricular tachycardia \[SVT\] or ventricular tachycardia with heart rate exceeding 110 beats per minute at Visit 1).
• ECG abnormalities precluding ST segment analysis on treadmill, or inability to walk on treadmill.
• Poorly controlled, symptomatic, active medical problems (HIV, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder).
• Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
• History of prostate cancer
• History of hypersensitivity to transdermal testosterone gel.
• International Prostate Symptom Score (IPSS) \>19 at Visit 1.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Abbott: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Mary Ann McLaughlin
• Organization: Icahn School of Medicine at Mount Sinai

maryann.mclaughlin@mountsinai.org

(212) 241-3340

Study Officials

• Mary Ann McLaughlin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 5, 2017
• Results First Posted: January 5, 2017

Record last verified: 2016-11

Locations

US (1)