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Introduction to Clinical Trials
Introduction to Clinical Trials
Review frequently asked questions and introductory information about clinical trials.
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List of Clinical Trials
Open Clinical Trial
The Cardiac Benefit of Androgen Replacement in Hypogonadal Males with Coronary Artery Disease Following Successful Percutaneous Coronary Intervention (PCI).
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of testosterone supplementation in hypogonadal men with coronary artery disease (narrowing of the arteries giving blood to the heart) following successful percutaneous coronary intervention (PCI),(procedure wherein blockage or narrowed artery is being dilated or stretched to allow better flow of blood in the heart).
Principal Investigator
Mary Ann McLaughlin
Phase
III
Compensation
Y
URL
www.clinicaltrials.gov
Inclusion
Inclusion criteria:
- Men age 40-75 years old with coronary artery disease (CAD).
- Stable heart condition 3 months after the percutaneous coronary intervention.
- No change in cardiac medications for 4 weeks before study entry.
- Low testosterone level.
- Prostate Specific Antigen (PSA)within normal range. This is a blood test used for prostate cancer detection.
Exclusion
Exclusion Criteria:
- Severe hypertension (blood pressure more than 180/110 or have a history of malignant hypertension).
- Significant irregular heart beat, (heart rate exceeding 110 beats per minute).
- Significant electrocardiogram (ECG) abnormalities during stress test, 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 Index Symptom Score (IPSS) >19. A questionnaire that asks about urine flow and urinary habits.
Research Study Site
Mount Sinai Medical Center
Department Name
MSSM Cardiovascular Institute
Contact Information
Lourdes Campos-Grundvig [Coordinator]
RN, MS
lourdes.campos-grundvig@mssm.edu
(212) 241-3141 43141
GCO Number
06-1081
IRB Start/End Date
November 29, 2008 to November 28, 2009
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