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

• Status: Recruiting
• Trial end date: 2022-06-22
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborators: AbbVie; Acerus Pharmaceuticals Corporation/ Aytu Biosciences Inc.; Allergan Sales LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories LLC; Acerus Pharmaceuticals Corporation/ Aytu Biosciences Inc.; Allergan Sales, LLC; Endo Pharmaceuticals; Upsher-Smith Laboratories LLC
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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).