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

Purpose

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.

Conditions

  • Hypogonadism
  • Cardiovascular Diseases

Eligibility

Eligible Ages
Between 45 Years and 80 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Drug: AndroGel®
    testosterone administered topically
Placebo Comparator
Placebo 		Participants receive matching placebo OD.
  • Drug: Placebo
    placebo administered topically

More Details

Status
Completed
Sponsor
AbbVie

Study Contact