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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT02222558
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic hypogonadal male subjects (Testosterone \> 100 and \<300 ng/dL, two separate 10 am samples one week apart),
* 18-70 years old,
* Willing and able to provide informed consent and to participate in all 3 periods of the study.
* BMI \< 35 kg/m2.
Exclusion Criteria:
* Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
* Alcoholics or substance abuse;
* Gastroparesis; IPSS (International Prostate Symptom score) \> 19; PSA (prostate-specific antigen)\> 4 ng/ml;
* Congestive Heart Failure, uncontrolled (NYHC \>1);
* Uncontrolled sleep apnea;
* Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
* Testopel excluded if within 2 years;
* Aveed excluded if within past 6 months;
* Hematocrit \> 50.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02222558
Study Brief:
Protocol Section:
NCT02222558