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:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT03126656
Eligibility Criteria:
Inclusion Criteria:
* Age between 40 and 70 aa with blood testosterone values \<11.4 nmol / L;
* Sinus rhythm at 12-lead ECG;
* Hypogonadism: Total Testosterone \<3.5 ng / ml or Free testosterone \<250 pmol / L (10 pg / mL) detected (8: 00-11: 00 am) in two successive measurements taken baseline and confirmed at 7 days apart, reduced libido and / or at least two symptoms of hypogonadism evaluated AMS questionnaire
* previous myocardial infarction and relief echocardiographic fraction of left ventricular ejection greater than or equal to 40% (in chronic heart failure patients);
* stable clinical and hemodynamic conditions for more than three months;
* No therapeutic changes in the last 3 months;
* signing the informed consent.
Exclusion Criteria:
* therapy with testosterone undertaken within 6 months of enrollment or other therapy with steroids undertaken within 3 months thereafter
* Clinical history of prostate cancer
* elevated PSA values (adjusted for age)
* digital rectal exploration (DRE) suggestive of prostate cancer
* Symptoms of benign prostatic hypertrophy (BPH) with severe obstructive symptoms
* Hematocrit\> 52% at baseline
* History of clinically significant hepatic, hematological, renal pathology
* Clinical history of breast cancer
* Hyperprolactinemia or other endocrine diseases (empty sella syndrome and pituitary expansive diseases measured by MRI)
* Age less than 40 or older than 70 years;
* Severe left ventricular systolic dysfunction (left ventricular ejection fraction \<40%) and / or echocardiographic evidence of severe valvular disease;
* chronic atrial fibrillation or frequent extrasystoles (\> 1 extrasystole / min);
* Presence of complete branch block;
* Unstable clinical and hemodynamic conditions and / or changes in therapy over the last three months;
* Presence of prostatic hyperplasia decisive severe obstruction to uroflow study;
* neoplasms diagnosed and treated less than five years later;
* Any other condition that medical judgment precludes patient safety
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03126656
Study Brief:
Protocol Section:
NCT03126656