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

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).

MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.

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.

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.

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).

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.

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.

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.

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.

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.

Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels >125 mg/dL, assessed at all available time points after baseline.

Presented as the number and percentage of participants who died, regardless of cause.

Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.

Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).

Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.

Presented as the number and percentage of participants who underwent prostate biopsy.

Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).

Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.

Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.

Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.