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 (TRAVERSE)

AbbVie

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Diseases; Hypogonadism

Treatments: Drug: Placebo; Drug: AndroGel®

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03518034

M16-100

Details and patient eligibility

About

This is a double-blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with pre-existing cardiovascular disease (CVD) or increased risk for CVD.

Enrollment: 5,246 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men between 45 and 80 years age
• Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion criteria

• Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
• Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
• Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
• Confirmed testosterone < 100 ng/dL
• Body Mass Index (BMI) > 50
• Hemoglobin A1c (HbA1C) > 11%
• Hematocrit (Hct) > 50%
• Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
• History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

5,246 participants in 2 patient groups, including a placebo group

AndroGel 1.62%

Active Comparator group

Description:

Participants receive topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may receive a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations are necessary.

Treatment:

Drug: AndroGel®

Placebo

Placebo Comparator group

Description:

Participants receive matching placebo OD.

Treatment:

Drug: Placebo