Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT03518034
Eligibility 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).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT03518034
Study Brief:
Protocol Section:
NCT03518034