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Testosterone Replacement in Older Men and Atherosclerosis Progression (TEAAM)

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ClinicalTrials.gov Identifier: NCT00287586
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Shalendar Bhasin, MD, Brigham and Women's Hospital

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
Enrollment 308
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description 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.) Participants received placebo-matching testosterone gel daily for 3 years.
Period Title: Overall Study
Started 156 152
Intent-to-treat: Received Study Drug 155 151
Completed 111 100
Not Completed 45 52
Reason Not Completed
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
Arm/Group Title Testosterone Placebo Total
Hide Arm/Group Description 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.) Participants received placebo-matching testosterone gel daily for 3 years. Total of all reporting groups
Overall Number of Baseline Participants 155 151 306
Hide Baseline Analysis Population Description
Intent-to-treat Population included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 151 participants 306 participants
66.9  (5.0) 68.3  (5.3) 67.6  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 151 participants 306 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
155
 100.0%
151
 100.0%
306
 100.0%
1.Primary Outcome
Title Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT)
Hide Description B-mode carotid artery images for IMT were acquired from the far wall of the distal centimeter of the right carotid artery with high-resolution ultrasound equipment. IMT is used as a predictor of the incidence of cardiovascular events. An increase in the IMT thickness is associated with a higher incidence of cardiovascular events. Less thickening is best. Change is expressed in millimeters (mm).
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 155 151
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 155 participants 151 participants
0.877  (0.210) 0.879  (0.199)
Change at Month 36 Number Analyzed 101 participants 92 participants
0.036  (0.059) 0.033  (0.077)
2.Primary Outcome
Title Change From Baseline in Coronary Artery Calcium Score
Hide Description A multiple detector computed tomography (MDCT) scan was performed. Proximal coronary arteries were visualized, and at least 30 consecutive images were obtained at 3-mm intervals. Coronary calcium was defined as a plaque of at least 3 contiguous pixels (area, 1.02 mm^2) with a density of more than 130 Hounsfield units.The lesion score was calculated by multiplying lesion area by a density factor derived from Hounsfield units. The Agatston method was used to determine the total calcium score by summing the lesion scores from the left main, left anterior descending, circumflex, and right coronary arteries. The Agatston score is the measure of calcification in arteries expressed on continuous scale with “0” value (better) indicating no calcification and score above 400 (worse) indicating high calcification. There is no upper limit for this measure. A positive change from baseline indicates a worsening.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 155 151
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 140 participants 132 participants
451.78  (715.41) 508.31  (694.87)
Change at Month 36 Number Analyzed 92 participants 92 participants
103.61  (289.45) 124.54  (208.42)
3.Secondary Outcome
Title Change From Baseline in Lipid Profiles
Hide Description Laboratory tests included in the lipid profile were Total Cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides.Lower values for Total Cholesterol, LDL-C are better and a negative change from Baseline indicates improvement. Higher values for HDL-C are better and a positive change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 155 151
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total Cholesterol, Baseline Number Analyzed 153 participants 147 participants
187.15  (42.09) 183.44  (36.68)
Total Cholesterol, Change at Month 36 Number Analyzed 101 participants 96 participants
-14.88  (35.92) -12.56  (33.90)
HDL-C, Baseline Number Analyzed 152 participants 146 participants
47.11  (11.97) 48.71  (14.21)
HDL-C, Change at Month 36 Number Analyzed 100 participants 95 participants
0.18  (9.69) 2.00  (11.08)
LDL-C, Baseline Number Analyzed 151 participants 146 participants
115.64  (35.18) 109.66  (31.86)
LDL-C, Change at Month 36 Number Analyzed 99 participants 95 participants
-11.24  (26.80) -13.92  (30.80)
Triglycerides, Baseline Number Analyzed 154 participants 146 participants
142.695  (87.93) 138.95  (76.37)
Triglycerides, Change at Month 36 Number Analyzed 101 participants 95 participants
-19.41  (73.69) -12.62  (84.62)
4.Secondary Outcome
Title Changes in Biomarkers of Inflammation
Hide Description [Not Specified]
Time Frame Three years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed. No funds were left to cover the costs of the assays for inflammation biomarkers.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Changes in Blood Pressure
Hide Description [Not Specified]
Time Frame Three years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No analysis was performed. Although blood pressure measurements were standardized within a trial site, there is a possibility that measurement techniques might have varied across the three trial sites over the trial’s long duration. For this reason we decided not to include blood pressure data in the results.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed)
Hide Description Cognitive Function was assessed by Complex Figure (Immediate) and (Delayed). The Complex Figure Test consists of three tasks: copy, immediate recall, and delayed recall. Participants were presented with a complex design and then asked to draw the same figure. Subsequently, they were instructed to draw what they remembered immediately, and after a 30 minute delay. Scoring was based on the number of correct items for a total possible score of 0 (worst) to 36 (Best). A positive change from Baseline indicates improvement. A negative change from Baseline indicates a worsening.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: correct items
Complex Figure:Immediate, Baseline Number Analyzed 124 participants 124 participants
20.95  (6.50) 20.31  (6.20)
Complex Figure:Immediate, Change at Month 36 Number Analyzed 84 participants 79 participants
-1.25  (4.90) -0.24  (6.11)
Complex Figure:Delayed, Baseline Number Analyzed 121 participants 124 participants
20.28  (6.08) 19.75  (6.11)
Complex Figure:Delayed, Change at Month 36 Number Analyzed 82 participants 77 participants
-0.49  (5.20) -0.24  (5.74)
7.Secondary Outcome
Title Change From Baseline in Paragraph Recall Test (Delayed)
Hide Description Cognitive Function was assessed by the Paragraph Recall Test (Delayed). In the Paragraph Recall Test, participants were read two short paragraphs and asked to recall them immediately and after a 30 minute delay, using the exact words that were read aloud. Scoring was based on the number of items correctly recalled. More items correctly recalled is best and a positive change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: correct items
Paragraph: Delayed, Baseline Number Analyzed 139 participants 139 participants
13.69  (6.37) 13.57  (6.12)
Paragraph:Delayed, Change at Month 36 Number Analyzed 92 participants 88 participants
2.15  (6.05) 1.72  (4.82)
8.Secondary Outcome
Title Change From Baseline in the Buschke Selective Reminding Test (Delayed)
Hide Description Cognitive function was assessed by the Buschke Selective Reminding Test. In the Buschke Selective Reminding Test, participants were read 12 words and asked to recall as many words as possible. Subsequent trials included only those words that were not recalled in the preceding trial. Individuals were also asked to recall the list 30 minutes later. To assess phonemic and category fluency, participants were asked to name as many items from a given category as possible in 1 minute. Higher number of correct items is best and a positive change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: correct items
Buschke Total Correct Delayed, Baseline Number Analyzed 138 participants 137 participants
8.00  (2.80) 7.76  (2.69)
Buschke Total Correct Delayed, Change at Month 36 Number Analyzed 96 participants 92 participants
0.47  (2.46) 0.85  (2.21)
9.Secondary Outcome
Title Change From Baseline in the Verbal Fluency Test
Hide Description Cognitive function was assessed by the Verbal Fluency Test. Participants were asked to name as many letters from a given category as possible in 1 minute. Higher number of letters is best and a positive change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: letters
Baseline Number Analyzed 137 participants 139 participants
26.96  (10.25) 27.02  (8.97)
Change at Month 36 Number Analyzed 96 participants 93 participants
2.86  (8.84) 1.77  (7.35)
10.Secondary Outcome
Title Change From Baseline in the Category Fluency Test
Hide Description Cognitive function was assessed by the Category Fluency Test. Participants were asked to name as many items from a given category as possible. Higher number of items named is best and a positive change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: items
Category Fluency, Baseline Number Analyzed 135 participants 138 participants
18.07  (5.61) 18.01  (5.62)
Category Fluency, Change at Month 36 Number Analyzed 95 participants 93 participants
2.25  (6.81) 0.37  (6.77)
11.Secondary Outcome
Title Change From Baseline in the Stroop Interference Test
Hide Description Cognitive function was assessed by the Stroop Interference Test. In the Stroop Interference Test, participants were presented with a word list of colors printed in ink of a color different from how the printed word read. Participants were instructed to read aloud the color of the ink in which a word was printed, while not verbalizing the word itself. The time in seconds that the items were correctly identified was recorded. Less time is better and a negative change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: seconds
Stroop Interference, Baseline Number Analyzed 137 participants 140 participants
55.64  (15.60) 56.84  (15.85)
Stroop Interference, Change at Month 36 Number Analyzed 95 participants 93 participants
-1.07  (14.48) 0.99  (16.10)
12.Secondary Outcome
Title Change From Baseline in the Trail Making Test B
Hide Description Cognitive function was assessed by the Trail Making Test B. Trail Making Test B involved participants connecting numbers (1–13) and letters (A–L) alternately (1–A, 2–B, etc) on a piece of paper as quickly as possible. Scores represent the time it takes the participant to complete the test. Less time is best and a negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with cognitive baseline data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 140 140
Mean (Standard Deviation)
Unit of Measure: seconds
Trails B, Baseline Number Analyzed 135 participants 131 participants
98.52  (42.40) 97.57  (31.82)
Trails B, Change at Month 36 Number Analyzed 82 participants 81 participants
3.88  (34.15) 11.26  (40.61)
13.Secondary Outcome
Title Change From Baseline in Chest Press Strength and Leg Press Strength
Hide Description Maximal voluntary strength of the lower and upper extremities was assessed using the one repetition maximum (1-RM) method for the seated leg press and chest press exercises. Participants were positioned with standardized seat position and foot placement that allowed 90° of knee flexion for the leg press exercise. Seat height and handle position was standardized for the chest press. Participants were familiarized with the exercises, practiced the technique and completed a 5-minute warm-up. The 1-RM procedure consisted of a warm up set with 5 to 8 repetitions at a resistance set to about 50% of the participant’s estimated 1-RM and progressed with increasing loads interspersed with standardized rest periods until the participant was able to perform only one full-range-of-motion repetition.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 135 121
Mean (Standard Deviation)
Unit of Measure: newton
Chest Press Strength, Baseline Number Analyzed 125 participants 110 participants
516.99  (133.37) 513.83  (104.92)
Chest Press Strength, Change at Month 36 Number Analyzed 82 participants 67 participants
-12.73  (54.20) -26.20  (40.88)
Leg Press Strength, Baseline Number Analyzed 128 participants 109 participants
2270.37  (424.81) 2233.74  (416.06)
Leg Press Strength, Change at Month 36 Number Analyzed 84 participants 68 participants
-37.26  (230.42) -65.33  (251.94)
14.Secondary Outcome
Title Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power
Hide Description Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: [body weight (kilograms) * distance (meters)/ (time/60)] /6.12. A negative change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with baseline physical function data and data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 135 121
Mean (Standard Deviation)
Unit of Measure: watts
Unloaded Stair Climb Power, Baseline Number Analyzed 116 participants 98 participants
536.33  (134.40) 535.78  (125.70)
Unloaded Stair Climb Power, Change at Month 36 Number Analyzed 77 participants 61 participants
-8.17  (71.60) -12.89  (64.28)
Loaded Stair Climb Power, Baseline Number Analyzed 106 participants 89 participants
581.24  (148.73) 594.84  (150.28)
Loaded Stair Climb Power, Change at Month 36 Number Analyzed 67 participants 54 participants
-8.44  (70.56) -12.76  (63.13)
15.Secondary Outcome
Title Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF)
Hide Description IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (6 questions), orgasmic function (2 questions), sexual desire (2 questions), intercourse satisfaction (3 questions), and overall sexual satisfaction (2 questions). Each question was answered on a 5-point scale from 1 to 5 (best) with a total possible score range of 0 to 75 with higher scores representing better function. A positive change from Baseline indicates improvement.
Time Frame Baseline and Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 155 151
Mean (Standard Deviation)
Unit of Measure: score on a scale
Erectile Function, Baseline Number Analyzed 129 participants 125 participants
18.33  (10.11) 18.67  (10.64)
Erectile Function, Change at Month 36 Number Analyzed 104 participants 94 participants
-0.15  (7.40) -0.80  (7.55)
Orgasmic Function, Baseline Number Analyzed 134 participants 126 participants
7.37  (3.61) 6.38  (3.86)
Orgasmic Function, Change at Month 36 Number Analyzed 108 participants 97 participants
-0.65  (3.35) 0.24  (3.44)
Sexual Desire, Baseline Number Analyzed 133 participants 125 participants
6.89  (2.04) 6.58  (2.19)
Sexual Desire, Change at Month 36 Number Analyzed 108 participants 96 participants
0.18  (1.94) 0.07  (1.87)
Intercourse Satisfaction, Baseline Number Analyzed 131 participants 127 participants
8.32  (5.92) 8.14  (5.94)
Intercourse Satisfaction, Change at Month 36 Number Analyzed 105 participants 97 participants
0.05  (4.56) -0.71  (4.11)
Overall Satisfaction, Baseline Number Analyzed 123 participants 116 participants
6.24  (2.84) 6.12  (2.64)
Overall Satisfaction, Change at Month 36 Number Analyzed 99 participants 87 participants
0.40  (2.77) 0.81  (2.54)
Total Score, Baseline Number Analyzed 117 participants 110 participants
48.48  (21.09) 49.67  (23.25)
Total Score, Change at Month 36 Number Analyzed 97 participants 85 participants
0.22  (15.54) -0.39  (15.32)
16.Secondary Outcome
Title Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36)
Hide Description The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. The Overall Score is the average of the individual domain scores. A negative change from Baseline indicates improvement.
Time Frame Baseline and Month 36
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Hide Analysis Population Description
All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point.
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description:
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.)
Participants received placebo-matching testosterone gel daily for 3 years.
Overall Number of Participants Analyzed 155 151
Mean (Standard Deviation)
Unit of Measure: score on a scale
Energy/Fatigue, Baseline Number Analyzed 60 participants 58 participants
69.92  (18.47) 71.21  (14.67)
Energy/Fatigue, Change at Month 36 Number Analyzed 39 participants 44 participants
-1.45  (13.40) -0.46  (12.57)
Emotional Well-Being, Baseline Number Analyzed 60 participants 58 participants
82.67  (12.64) 83.17  (11.38)
Emotional Well-Being, Change at Month 36 Number Analyzed 39 participants 44 participants
-1.16  (14.76) 0.91  (11.60)
Role Limitations/Emotional Problems, Baseline Number Analyzed 60 participants 58 participants
90.00  (23.21) 89.08  (26.04)
Role Limitations/Emotional Problems,Change Number Analyzed 39 participants 44 participants
3.51  (32.69) -9.09  (34.00)
Social Functioning, Baseline Number Analyzed 60 participants 58 participants
90.42  (16.17) 92.89  (13.06)
Social Functioning, Change at Month 36 Number Analyzed 39 participants 44 participants
-3.29  (22.64) -4.83  (14.06)
Physical Functioning, Baseline Number Analyzed 60 participants 58 participants
82.00  (20.15) 83.28  (18.79)
Physical Functioning, Change at Month 36 Number Analyzed 39 participants 44 participants
-3.82  (21.20) -2.39  (21.09)
Role Limitations/Physical Health, Baseline Number Analyzed 60 participants 58 participants
80.00  (30.81) 88.79  (21.55)
Role Limitations,/Physical Health, Change Number Analyzed 39 participants 44 participants
-1.97  (24.23) -9.66  (34.61)
Pain, Baseline Number Analyzed 60 participants 58 participants
82.83  (17.29) 82.24  (15.84)
Pain, Change at Month 36 Number Analyzed 39 participants 44 participants
-7.96  (14.81) -5.97  (17.90)
General Health, Baseline Number Analyzed 60 participants 58 participants
74.17  (19.51) 76.72  (15.18)
General Health, Change at Month 36 Number Analyzed 39 participants 44 participants
-0.53  (11.90) -3.75  (14.59)
Overall Score, Baseline Number Analyzed 60 participants 58 participants
81.50  (14.12) 83.42  (12.45)
Overall Score, Change at Month 36 Number Analyzed 39 participants 44 participants
-2.08  (11.88) -4.40  (12.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone Placebo
Hide Arm/Group Description 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.) Participants received placebo-matching testosterone gel daily for 3 years.
All-Cause Mortality
Testosterone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   24/155 (15.48%)   25/151 (16.56%) 
Cardiac disorders     
Angina pectoris   1/155 (0.65%)  3/151 (1.99%) 
Congestive heart failure   0/155 (0.00%)  1/151 (0.66%) 
Congestive heart failure exacerbation   0/155 (0.00%)  1/151 (0.66%) 
Pulseless electrical activity (PEA) cardiac arrest   0/155 (0.00%)  1/151 (0.66%) 
Slient myocardial infarction   0/155 (0.00%)  1/151 (0.66%) 
Sinus bradycardia   0/155 (0.00%)  1/151 (0.66%) 
Acute posterior myocardial infarction   1/155 (0.65%)  0/151 (0.00%) 
Coronary artery disease   1/155 (0.65%)  0/151 (0.00%) 
Coronary heart disease   1/155 (0.65%)  0/151 (0.00%) 
Myocardial infarction   2/155 (1.29%)  0/151 (0.00%) 
Second-degree atrioventricular heart block   1/155 (0.65%)  0/151 (0.00%) 
Gastrointestinal disorders     
Colonic diverticulitis   0/155 (0.00%)  1/151 (0.66%) 
Upper gastrointestinal bleeding   0/155 (0.00%)  1/151 (0.66%) 
General disorders     
Death   1/155 (0.65%)  6/151 (3.97%) 
Chest pain   1/155 (0.65%)  1/151 (0.66%) 
Exertional chest pains   1/155 (0.65%)  0/151 (0.00%) 
Leg pain   1/155 (0.65%)  0/151 (0.00%) 
Infections and infestations     
Appendicitis   0/155 (0.00%)  1/151 (0.66%) 
Bacterial septicemia   0/155 (0.00%)  1/151 (0.66%) 
Colitis with abscess and fistula   0/155 (0.00%)  1/151 (0.66%) 
E.coli infection   0/155 (0.00%)  1/151 (0.66%) 
Meningitis not otherwise specified (NOS)   0/155 (0.00%)  1/151 (0.66%) 
Bacteriemia   0/155 (0.00%)  1/151 (0.66%) 
Pneumonia   1/155 (0.65%)  1/151 (0.66%) 
Aspiration pneumonia   1/155 (0.65%)  0/151 (0.00%) 
Bilateral toe gangrene   1/155 (0.65%)  0/151 (0.00%) 
Cellulites on right foot and calf   1/155 (0.65%)  0/151 (0.00%) 
Injury, poisoning and procedural complications     
Mugged  [1]  0/155 (0.00%)  1/151 (0.66%) 
Coronary angiogram resulted in 2 occluded vessels   0/155 (0.00%)  1/151 (0.66%) 
Investigations     
Elevated blood pressure   1/155 (0.65%)  0/151 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycemia   0/155 (0.00%)  1/151 (0.66%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pulmonary carcinoma complications  [2]  0/155 (0.00%)  1/151 (0.66%) 
Pancreatic cancer  [2]  0/155 (0.00%)  1/151 (0.66%) 
Lung mass   0/155 (0.00%)  1/151 (0.66%) 
Glioma   0/155 (0.00%)  1/151 (0.66%) 
Melanoma   0/155 (0.00%)  1/151 (0.66%) 
Bladder cancer   0/155 (0.00%)  1/151 (0.66%) 
Lung cancer reaccurence   0/155 (0.00%)  1/151 (0.66%) 
Prostate cancer   3/155 (1.94%)  2/151 (1.32%) 
Lung pulmonary nodule   0/155 (0.00%)  1/151 (0.66%) 
Squamous cell carcinoma   0/155 (0.00%)  1/151 (0.66%) 
Colon cancer   2/155 (1.29%)  0/151 (0.00%) 
Cerebellar neoplasm   1/155 (0.65%)  0/151 (0.00%) 
Localized prostate adeno-carcinoma   1/155 (0.65%)  0/151 (0.00%) 
Neoplasm left kidney   1/155 (0.65%)  0/151 (0.00%) 
Pancreatic tumor   1/155 (0.65%)  0/151 (0.00%) 
Nervous system disorders     
Cerebrovascular accident (CVA)   3/155 (1.94%)  0/151 (0.00%) 
Herniated free fragment with right lumbar radiculopathy   1/155 (0.65%)  0/151 (0.00%) 
Right hemispheric subacute stroke   1/155 (0.65%)  0/151 (0.00%) 
Renal and urinary disorders     
Renal artery stenosis   0/155 (0.00%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  [2]  0/155 (0.00%)  1/151 (0.66%) 
Surgical and medical procedures     
Appendectomy   0/155 (0.00%)  1/151 (0.66%) 
Triple by-pass surgery   0/155 (0.00%)  1/151 (0.66%) 
Coronary artery bypass graft   0/155 (0.00%)  1/151 (0.66%) 
Complete ankle replacement surgery   0/155 (0.00%)  1/151 (0.66%) 
Coronary stent procedure   1/155 (0.65%)  1/151 (0.66%) 
Angioplasty   2/155 (1.29%)  0/151 (0.00%) 
Complete left knee replacement surgery   1/155 (0.65%)  0/151 (0.00%) 
Quadruple by-pass surgery   1/155 (0.65%)  0/151 (0.00%) 
Right knee re-placement surgery   1/155 (0.65%)  0/151 (0.00%) 
Dual chamber pace maker placement   1/155 (0.65%)  0/151 (0.00%) 
Vascular disorders     
Saphenous vein graft occlusion   1/155 (0.65%)  0/151 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Resulted in death
[2]
Resulting in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Testosterone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   33/155 (21.29%)   20/151 (13.25%) 
Infections and infestations     
Upper respiratory infection   12/155 (7.74%)  12/151 (7.95%) 
Investigations     
Elevated Prostate-Specific Antigen (PSA)   16/155 (10.32%)  9/151 (5.96%) 
Elevated hematocrit (HCT)   8/155 (5.16%)  0/151 (0.00%) 
Indicates events were collected by systematic assessment
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
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