Testosterone Replacement in Older Men and Atherosclerosis Progression
NCT00287586, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2017-06-29
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Testosterone Replacement in Older Men and Atherosclerosis Progression | ClinicalTrials.gov |
| NCT number | NCT00287586 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 308 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Brigham and Women's Hospital | ClinicalTrials.gov |
| Conditions | Hypogonadism, Atherosclerosis | ClinicalTrials.gov |
| Interventions | Testosterone Gel (Androgel), Placebo | ClinicalTrials.gov |
| First posted | 2006-02-07 | ClinicalTrials.gov |
| Last updated | 2017-06-29 | ClinicalTrials.gov |
| Results first posted | 2017-06-29 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) | Baseline and Month 36 | 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). | ClinicalTrials.gov |
| Primary | Change From Baseline in Coronary Artery Calcium Score | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Lipid Profiles | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Changes in Biomarkers of Inflammation | Three years | ClinicalTrials.gov | |
| Secondary | Changes in Blood Pressure | Three years | ClinicalTrials.gov | |
| Secondary | Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed) | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Paragraph Recall Test (Delayed) | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in the Buschke Selective Reminding Test (Delayed) | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in the Verbal Fluency Test | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in the Category Fluency Test | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in the Stroop Interference Test | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in the Trail Making Test B | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Chest Press Strength and Leg Press Strength | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF) | Baseline and Month 36 | 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. | ClinicalTrials.gov |
| Secondary | Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) | Baseline and Month 36 | 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. | ClinicalTrials.gov |
Outcomes 16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) | Baseline and Month 36 | All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point. | mm | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Coronary Artery Calcium Score | Baseline and Month 36 | All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Lipid Profiles | Baseline and Month 36 | All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point. | mg/dL | MEAN | ClinicalTrials.gov |
| SECONDARY | Changes in Biomarkers of Inflammation | Three years | No analysis was performed. No funds were left to cover the costs of the assays for inflammation biomarkers. | ClinicalTrials.gov | ||
| SECONDARY | Changes in Blood Pressure | Three years | 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. | ClinicalTrials.gov | ||
| SECONDARY | Change From Baseline in Complex Figure (Immediate) and Complex Figure (Delayed) | Baseline and Month 36 | 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. | correct items | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Paragraph Recall Test (Delayed) | Baseline and Month 36 | 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. | correct items | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in the Buschke Selective Reminding Test (Delayed) | Baseline and Month 36 | 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. | correct items | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in the Verbal Fluency Test | Baseline and Month 36 | 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. | letters | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in the Category Fluency Test | Baseline and Month 36 | 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. | items | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in the Stroop Interference Test | Baseline and Month 36 | 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. | seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in the Trail Making Test B | Baseline and Month 36 | 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. | seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Chest Press Strength and Leg Press Strength | Baseline and Month 36 | 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. | newton | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Unloaded Stair Climb Power and Loaded Stair Climb Power | Baseline and Month 36 | 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. | watts | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Sexual Function as Assessed by the International Index of Erectile Function (IIEF) | Baseline and Month 36 | All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) | Baseline and Month 36 | All participants from the Intent-to-treat population, all randomized and treated participants, with data available at the given time-point. | score on a scale | MEAN | ClinicalTrials.gov |
Results by group 132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) | Testosterone | Baseline | 0.877 | Standard Deviation 0.210 | mm | ClinicalTrials.gov |
| Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) | Placebo | Baseline | 0.879 | Standard Deviation 0.199 | mm | ClinicalTrials.gov |
| Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) | Testosterone | Change at Month 36 | 0.036 | Standard Deviation 0.059 | mm | ClinicalTrials.gov |
| Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) | Placebo | Change at Month 36 | 0.033 | Standard Deviation 0.077 | mm | ClinicalTrials.gov |
| Change From Baseline in Coronary Artery Calcium Score | Testosterone | Baseline | 451.78 | Standard Deviation 715.41 | score on a scale | ClinicalTrials.gov |
| Change From Baseline in Coronary Artery Calcium Score | Placebo | Baseline | 508.31 | Standard Deviation 694.87 | score on a scale | ClinicalTrials.gov |
| Change From Baseline in Coronary Artery Calcium Score | Testosterone | Change at Month 36 | 103.61 | Standard Deviation 289.45 | score on a scale | ClinicalTrials.gov |
| Change From Baseline in Coronary Artery Calcium Score | Placebo | Change at Month 36 | 124.54 | Standard Deviation 208.42 | score on a scale | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Testosterone | Total Cholesterol, Baseline | 187.15 | Standard Deviation 42.09 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Placebo | Total Cholesterol, Baseline | 183.44 | Standard Deviation 36.68 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Testosterone | Total Cholesterol, Change at Month 36 | -14.88 | Standard Deviation 35.92 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Placebo | Total Cholesterol, Change at Month 36 | -12.56 | Standard Deviation 33.90 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Testosterone | HDL-C, Baseline | 47.11 | Standard Deviation 11.97 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Placebo | HDL-C, Baseline | 48.71 | Standard Deviation 14.21 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Testosterone | HDL-C, Change at Month 36 | 0.18 | Standard Deviation 9.69 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Placebo | HDL-C, Change at Month 36 | 2.00 | Standard Deviation 11.08 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Testosterone | LDL-C, Baseline | 115.64 | Standard Deviation 35.18 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Placebo | LDL-C, Baseline | 109.66 | Standard Deviation 31.86 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Testosterone | LDL-C, Change at Month 36 | -11.24 | Standard Deviation 26.80 | mg/dL | ClinicalTrials.gov |
| Change From Baseline in Lipid Profiles | Placebo | LDL-C, Change at Month 36 | -13.92 | Standard Deviation 30.80 | mg/dL | ClinicalTrials.gov |
Participant flow 8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Testosterone | 156 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 152 | ClinicalTrials.gov | |
| Overall Study | Intent-to-treat: Received Study Drug | Testosterone | 155 | ClinicalTrials.gov | |
| Overall Study | Intent-to-treat: Received Study Drug | Placebo | 151 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Testosterone | 111 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 100 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Testosterone | 45 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 52 | ClinicalTrials.gov |
Adverse events 130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Elevated Prostate-Specific Antigen (PSA) | Investigations | Testosterone | 16 | 155 | ClinicalTrials.gov | |
| other | Elevated Prostate-Specific Antigen (PSA) | Investigations | Placebo | 9 | 151 | ClinicalTrials.gov | |
| other | Upper respiratory infection | Infections and infestations | Testosterone | 12 | 155 | ClinicalTrials.gov | |
| other | Upper respiratory infection | Infections and infestations | Placebo | 12 | 151 | ClinicalTrials.gov | |
| other | Elevated hematocrit (HCT) | Investigations | Testosterone | 8 | 155 | ClinicalTrials.gov | |
| other | Elevated hematocrit (HCT) | Investigations | Placebo | 0 | 151 | ClinicalTrials.gov | |
| serious | Death | General disorders | Testosterone | 1 | 155 | ClinicalTrials.gov | |
| serious | Death | General disorders | Placebo | 6 | 151 | ClinicalTrials.gov | |
| serious | Pulmonary carcinoma complications | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Testosterone | 0 | 155 | ClinicalTrials.gov | |
| serious | Pulmonary carcinoma complications | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 151 | ClinicalTrials.gov | |
| serious | Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Testosterone | 0 | 155 | ClinicalTrials.gov | |
| serious | Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 151 | ClinicalTrials.gov | |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Testosterone | 0 | 155 | ClinicalTrials.gov | |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 151 | ClinicalTrials.gov | |
| serious | Angina pectoris | Cardiac disorders | Testosterone | 1 | 155 | ClinicalTrials.gov | |
| serious | Angina pectoris | Cardiac disorders | Placebo | 3 | 151 | ClinicalTrials.gov | |
| serious | Appendicitis | Infections and infestations | Testosterone | 0 | 155 | ClinicalTrials.gov | |
| serious | Appendicitis | Infections and infestations | Placebo | 1 | 151 | ClinicalTrials.gov | |
| serious | Appendectomy | Surgical and medical procedures | Testosterone | 0 | 155 | ClinicalTrials.gov | |
| serious | Appendectomy | Surgical and medical procedures | Placebo | 1 | 151 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Testosterone | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Testosterone | 33 | 155 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 20 | 151 | ClinicalTrials.gov |
| Total, serious adverse events | Testosterone | 24 | 155 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 25 | 151 | ClinicalTrials.gov |
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Testosterone vs Placebo: serious adverse events | Trial comparisons |
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)