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Lay Description

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.

Category

  • Heart, Vascular and Blood
IRB Number
20190106HU
NCT Number
NCT03518034
Open to Enrollment
Yes

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

Arm Groups

Study Contact


Regulatory Point of Contact
Emina Case
emina.morina@va.gov

Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Regulatory Point of Contact
Susan Kaiser
susan.kaiser@va.gov

Regulatory Point of Contact
Devjit Tripathy
(210) 567-6691
tripathy@uthscsa.edu

Local Recruitment Point of Contact
Emina Case
emina.morina@va.gov

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Susan Kaiser
susan.kaiser@va.gov

Principal Investigator
Devjit Tripathy