Trial · NCT03518034
A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
NCT03518034, Phase 4, Completed, AbbVie; results first posted 2024-03-13
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men. Trials, record NCT03518034. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03518034
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men
- NCT number
- NCT03518034
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 5,246 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Hypogonadism, Cardiovascular Diseases
- Interventions
- AndroGel®, Placebo
- First posted
- 2018-05-08
- Last updated
- 2024-03-13
- Results first posted
- 2024-03-13
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months) | MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC). |
| Primary | Time From Randomization to the First Component Event of MACE | Randomization to event or last known date if no event (up to approximately 52 months) | MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC. |
| Secondary | Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months). | The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC. |
| Secondary | Time From Randomization to the First Component Event of CV Safety Endpoint | Randomization to event or last known date if no event (up to approximately 52 months). | The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC. |
| Secondary | Incidence of High-Grade Prostate Cancer | Randomization to event or last known date if no event (up to approximately 52 months). | Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3). |
| Other | Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 | From Baseline to Months 6, 12, and 24 | PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity. |
| Other | Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition | Months 6, 12, 24 | The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score \<5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome. |
| Other | Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months). | Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded. |
| Other | Time From Randomization to First Clinical Fracture | Randomization to event or maximum follow-up (up to approximately 52 months). | Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded. |
| Other | Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period | Baseline, Months 6, 12, 24, 36 and 48 | The correction of anemia was defined as an increase in hemoglobin level \>12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months) | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time From Randomization to the First Component Event of MACE | Randomization to event or last known date if no event (up to approximately 52 months) | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | months | MEDIAN |
| SECONDARY | Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomization to the First Component Event of CV Safety Endpoint | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | months | MEDIAN |
| SECONDARY | Incidence of High-Grade Prostate Cancer | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24 | From Baseline to Months 6, 12, and 24 | TRAVERSE Sexual Function Sub-Study: participants in the TRAVERSE main study full analysis set (i.e., randomized, no duplicate/triplicate participant IDs) who were eligible for the sexual function sub-study. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition | Months 6, 12, 24 | PDD Sub-Study participants (those included TRAVERSE main study full analysis set participants \[i.e., randomized, no duplicate/triplicate participant IDs\] who met the criteria for low-grade PDD) with an assessment at given time point. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event | Randomization to event or last known date if no event (up to approximately 52 months). | TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time From Randomization to First Clinical Fracture | Randomization to event or maximum follow-up (up to approximately 52 months). | TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period | Baseline, Months 6, 12, 24, 36 and 48 | All randomized participants in TRAVERSE main study who had anemia at baseline; participants with an assessment at given time point. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event | AndroGel 1.62% | 182 | Participants | ||
| Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event | Placebo | 190 | Participants | ||
| Time From Randomization to the First Component Event of MACE | AndroGel 1.62% | NA | 95% Confidence Interval NA to NA | months | |
| Time From Randomization to the First Component Event of MACE | Placebo | NA | 95% Confidence Interval NA to NA | months | |
| Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event | AndroGel 1.62% | 269 | Participants | ||
| Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event | Placebo | 264 | Participants | ||
| Time From Randomization to the First Component Event of CV Safety Endpoint | AndroGel 1.62% | NA | 95% Confidence Interval NA to NA | months | |
| Time From Randomization to the First Component Event of CV Safety Endpoint | Placebo | NA | 95% Confidence Interval NA to NA | months | |
| Incidence of High-Grade Prostate Cancer | AndroGel 1.62% | 5 | Participants | ||
| Incidence of High-Grade Prostate Cancer | Placebo | 3 | Participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AndroGel 1.62% | 2,601 | |
| Overall Study | STARTED | Placebo | 2,603 | |
| Overall Study | Participants in Safety Analysis Set (Randomized, Treated, no Duplicate/Triplicate Participant IDs) | AndroGel 1.62% | 2,596 | |
| Overall Study | Participants in Safety Analysis Set (Randomized, Treated, no Duplicate/Triplicate Participant IDs) | Placebo | 2,602 | |
| Overall Study | COMPLETED | AndroGel 1.62% | 1,594 | |
| Overall Study | COMPLETED | Placebo | 1,581 | |
| Overall Study | NOT COMPLETED | AndroGel 1.62% | 1,007 | |
| Overall Study | NOT COMPLETED | Placebo | 1,022 |
Source ClinicalTrials.gov
Adverse events2,668
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 |
|---|---|---|---|---|---|---|
| other | DIABETES MELLITUS | Metabolism and nutrition disorders | AndroGel 1.62% Predose | 0 | 0 | |
| other | DIABETES MELLITUS | Metabolism and nutrition disorders | Placebo Predose | 0 | 0 | |
| other | DIABETES MELLITUS | Metabolism and nutrition disorders | AndroGel 1.62% | 160 | 2,596 | 169 |
| other | DIABETES MELLITUS | Metabolism and nutrition disorders | Placebo | 170 | 2,602 | 183 |
| serious | ANAEMIA | Blood and lymphatic system disorders | AndroGel 1.62% Predose | 0 | 2,601 | 0 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Placebo Predose | 0 | 2,603 | 0 |
| serious | ANAEMIA | Blood and lymphatic system disorders | AndroGel 1.62% | 7 | 2,601 | 7 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Placebo | 6 | 2,603 | 7 |
| serious | BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | AndroGel 1.62% Predose | 0 | 2,601 | 0 |
| serious | BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | Placebo Predose | 0 | 2,603 | 0 |
1 to 10 of 2,668Source ClinicalTrials.gov
See all 2,668 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AndroGel 1.62% Predose | 0 | 2,601 |
| Total, all-cause mortality | Placebo Predose | 0 | 2,603 |
| Total, all-cause mortality | AndroGel 1.62% | 144 | 2,601 |
| Total, all-cause mortality | Placebo | 148 | 2,603 |
| Total, other adverse events | AndroGel 1.62% Predose | 0 | 0 |
| Total, other adverse events | Placebo Predose | 0 | 0 |
| Total, other adverse events | AndroGel 1.62% | 160 | 2,601 |
| Total, other adverse events | Placebo | 170 | 2,603 |
| Total, serious adverse events | AndroGel 1.62% Predose | 19 | 2,601 |
| Total, serious adverse events | Placebo Predose | 10 | 2,603 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of Heart Failure | Trial comparisons |
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of All Cause Mortality | Trial comparisons |
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of Prostate Cancer | Trial comparisons |
| AndroGel 1.62% vs Placebo: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event | Trial comparisons |
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of Acute Urinary Retention | Trial comparisons |
| AndroGel 1.62% vs Placebo: Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event | Trial comparisons |
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms | Trial comparisons |
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization | Trial comparisons |
| AndroGel 1.62% vs Placebo: Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia | Trial comparisons |
| AndroGel 1.62% vs Placebo: Incidence of High-Grade Prostate Cancer | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03518034
GET https://conductscience.org/api/trials/v1/NCT03518034/results?page=2