Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study
Overview
- Phase
- Phase 4
- Intervention
- AndroGel®
- Conditions
- Hypogonadism
- Sponsor
- AbbVie
- Enrollment
- 5246
- Locations
- 384
- Primary Endpoint
- Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
AndroGel 1.62%
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.
Intervention: AndroGel®
Placebo
Participants receive matching placebo OD.
Intervention: Placebo
Outcomes
Primary Outcomes
Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event
Time Frame: 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).
Time From Randomization to the First Component Event of MACE
Time Frame: 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 Outcomes
- Incidence of High-Grade Prostate Cancer(Randomization to event or last known date if no event (up to approximately 52 months).)
- 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).)
- 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).)