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Testosterone Replacement in Older Men and Atherosclerosis Progression (TEAAM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287586
First Posted: February 7, 2006
Last Update Posted: June 29, 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:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Shalendar Bhasin, MD, Brigham and Women's Hospital
Results First Submitted: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Hypogonadism
Atherosclerosis
Interventions: Drug: Testosterone Gel (Androgel)
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
No text entered.

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
Testosterone Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
Placebo Participants received placebo-matching testosterone gel daily for 3 years.

Participant Flow:   Overall Study
    Testosterone   Placebo
STARTED   156   152 
Intent-to-treat: Received Study Drug   155   151 
COMPLETED   111   100 
NOT COMPLETED   45   52 
Withdrew Consent                19                30 
Lost to Follow-up                5                4 
Death                2                3 
Elevated Hematocrit                3                0 
Rash                3                0 
Elevated Prostate Specific Antigen                2                0 
Stroke                2                0 
Myocardial Infarction                1                0 
Lower Urinary Tract Symptoms                1                0 
Cognitive Impairment                1                0 
Pancreatic Cancer                1                3 
Sleep Apnea                1                0 
Shoulder Pain                1                0 
Inappropriate Behaviour with Staff                1                0 
Nonadherence                1                1 
Enrolled in Another Study                1                0 
Major Depression                0                2 
Lung Cancer                0                2 
Elevated IPSS Score                0                1 
Retroperitoneal Cancer                0                1 
Mastodynia and Gynecomastia                0                1 
Mood Swings and Irritability                0                1 
Bradycardia                0                1 
Itchy Swollen Eyes                0                1 
Recurrent Melanoma                0                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.
Intent-to-treat Population included all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Testosterone Participants received 7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years. Dose adjustments were made by an unblinded observer. (Serum testosterone level measured on treatment day 15 was measured in a sample sent separately to the laboratory such that the results were reported directly to unblinded physician, who then communicated the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.)
Placebo Participants received placebo-matching testosterone gel daily for 3 years.
Total Total of all reporting groups

Baseline Measures
   Testosterone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   151   306 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.9  (5.0)   68.3  (5.3)   67.6  (5.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      155 100.0%      151 100.0%      306 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)   [ Time Frame: Baseline and Month 36 ]

2.  Primary:   Change From Baseline in Coronary Artery Calcium Score   [ Time Frame: Baseline and Month 36 ]

3.  Secondary:   Change From Baseline in Lipid Profiles   [ Time Frame: Baseline and Month 36 ]

4.  Secondary:   Changes in Biomarkers of Inflammation   [ Time Frame: Three years ]

5.  Secondary:   Changes in Blood Pressure   [ Time Frame: Three years ]

6.  Secondary:   Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)   [ Time Frame: Baseline and Month 36 ]

7.  Secondary:   Change From Baseline in Paragraph Recall Test (Delayed)   [ Time Frame: Baseline and Month 36 ]

8.  Secondary:   Change From Baseline in the Buschke Selective Reminding Test (Delayed)   [ Time Frame: Baseline and Month 36 ]

9.  Secondary:   Change From Baseline in the Verbal Fluency Test   [ Time Frame: Baseline and Month 36 ]

10.  Secondary:   Change From Baseline in the Category Fluency Test   [ Time Frame: Baseline and Month 36 ]

11.  Secondary:   Change From Baseline in the Stroop Interference Test   [ Time Frame: Baseline and Month 36 ]

12.  Secondary:   Change From Baseline in the Trail Making Test B   [ Time Frame: Baseline and Month 36 ]

13.  Secondary:   Change From Baseline in Chest Press Strength and Leg Press Strength   [ Time Frame: Baseline and Month 36 ]

14.  Secondary:   Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power   [ Time Frame: Baseline and Month 36 ]

15.  Secondary:   Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)   [ Time Frame: Baseline and Month 36 ]

16.  Secondary:   Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)   [ Time Frame: Baseline and Month 36 ]


  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: Shalendar Bhasin, MD
Organization: Brigham and Women's Hospital
e-mail: Sbhasin@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shalendar Bhasin, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00287586     History of Changes
Other Study ID Numbers: H-24192
First Submitted: February 6, 2006
First Posted: February 7, 2006
Results First Submitted: March 28, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017