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
This is a blinded and placebo-controlled study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.
- Cardiovascular Diseases
- Eligible Ages
- Between 45 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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).
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Participants receiving topical testosterone||
|Participants receiving placebo||
Study ContactABBVIE CALL CENTER