Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.