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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413244
First Posted: December 19, 2006
Last Update Posted: January 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
Results First Submitted: May 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: AndroGel 5 Grams
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited for the study were male patients with stable cardiac status at least 3 months after Percutaneous Coronary Intervention (PCI) at the Cardiac Catheterization Lab of Mount Sinai Hospital from July 2007 to August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Androgel Androgel 5 grams
Placebo Matching Placebo

Participant Flow:   Overall Study
    Androgel   Placebo
STARTED   31   20 
COMPLETED   21   19 
NOT COMPLETED   10   1 
Withdrawal by Subject                10                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Androgel Androgel 5 grams
Placebo Matching Placebo
Total Total of all reporting groups

Baseline Measures
   Androgel   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   20   51 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (8.2)   58.9  (7.3)   58.5  (7.81) 
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      31 100.0%      20 100.0%      51 100.0% 
Hypertension 
[Units: Participants]
     
Yes   30   16   46 
No   1   4   5 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.8  (5.8)   28.0  (4.3)   29.7  (5.4) 
Diabetes 
[Units: Participants]
     
Yes   16   6   22 
No   15   14   29 
Total Testosterone 
[Units: ng/dL]
Mean (Standard Deviation)
 246.7  (63.5)   263.7  (71.9)   253.36  (66.8) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 123.81  (13.81)   128.05  (20.84)   125.47  (16.85) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 76.32  (9.03)   75.10  (11.65)   75.84  (10.04) 
Hematocrit 
[Units: Percent of cells]
Mean (Standard Deviation)
 40.69  (3.00)   40.93  (3.18)   40.78  (3.04) 
White Blood Cell Count 
[Units: Cells x10^3/uL]
Mean (Standard Deviation)
 6.25  (1.78)   6.49  (1.63)   6.34  (1.71) 
Red Blood Cell Count 
[Units: Cells x10^6/uL]
Mean (Standard Deviation)
 4.58  (0.44)   4.67  (0.42)   4.62  (0.43) 
Aging male syndrome questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 36.48  (11.36)   35.85  (10.24)   36.24  (10.83) 
[1] The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)
Exercise Time 
[Units: Seconds]
Mean (Standard Deviation)
 507.29  (153.48)   530.00  (120.08)   516.20  (104.49) 
International Prostate Symptom Score (IPSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.68  (4.77)   4.55  (4.7)   5.24  (4.73) 
[1] IPSS has 8 questions total - 7 questions related to symptoms, each item scored 1-5. (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 ("delighted" to "terrible".) Total scale ranges from 8-35. Mild (symptom score less than of equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35)
Metabolic equivalent of task (METs) 
[Units: MET units]
Mean (Standard Deviation)
 10.03  (2.58)   10.05  (1.99)   10.04  (2.34) 
Reactive hyperemia index (RHI) 
[Units: Ml]
Mean (Standard Deviation)
 1.97  (0.72)   1.85  (0.54)   1.92  (0.66) 
Total Cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 157.29  (47.10)   144.45  (28.85)   152.25  (41.08) 
LDL 
[Units: mg/dL]
Mean (Standard Deviation)
 86.48  (40.52)   80.90  (26.77)   84.29  (35.57) 
Triglycerides 
[Units: mg/dL]
Mean (Standard Deviation)
 142.23  (100.95)   109.90  (50.86)   129.55  (85.74) 
Waist Circumference 
[Units: Inches]
Mean (Standard Deviation)
 42.66  (5.21)   41.31  (4.65)   42.13  (4.99) 
Weight 
[Units: Lbs]
Mean (Standard Deviation)
 205.73  (39.22)   194.50  (36.62)   201.32  (38.25) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cardiac Stress Test: Time to ST Depression   [ Time Frame: at 6 months ]

2.  Primary:   Cardiac Stress Testing: Exercise Capacity   [ Time Frame: At 1 month, 3 months, and 6 months ]

3.  Secondary:   Seattle Angina Questionnaire (SAQ)   [ Time Frame: up to 6 months ]

4.  Secondary:   Reactive Hyperemia Index   [ Time Frame: 6 months ]

5.  Secondary:   International Prostate Symptom Score (IPSS)   [ Time Frame: 6 months ]

6.  Secondary:   Metabolic Equivalents of Task (METS)   [ Time Frame: 6 months ]

7.  Secondary:   Aging Male Symptoms (AMS)   [ Time Frame: At baseline, 1 month, 3 months, and 6 months ]

8.  Secondary:   International Index of Erectile Function (IIEF)   [ Time Frame: At baseline, 1 month, 3 months, and 6 months ]

9.  Secondary:   IIEF-II Orgasmic Function   [ Time Frame: At baseline, 1 month, 3 months, and 6 months ]

10.  Secondary:   IIEF -III: Sexual Desire   [ Time Frame: At baseline, 1 month, 3 months, and 6 months ]

11.  Secondary:   IIEF-IV: Intercourse Satisfaction   [ Time Frame: At baseline, 1 month, 3 months, and 6 months ]

12.  Secondary:   IIEF-V: Over-all Satisfaction   [ Time Frame: At baseline, 1 month, 3 months, and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mary Ann McLaughlin
Organization: Icahn School of Medicine at Mount Sinai
phone: (212) 241-3340
e-mail: maryann.mclaughlin@mountsinai.org



Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00413244     History of Changes
Other Study ID Numbers: GCO 06-1081
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: May 25, 2016
Results First Posted: January 5, 2017
Last Update Posted: January 5, 2017



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