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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT01717768
Eligibility Criteria:
Inclusion Criteria:
* Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone \< 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
* Men over the age of 18 years with a body mass index (BMI) \< 39.0 kg/m2 and weighing ≥ 55 kg
* Hemoglobin levels at screening and baseline \> 12.5 g/dL
* Testosterone treatment not contraindicated
* No evidence of suspected reversible hypogonadism
* Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
* Understands the requirements of the study and voluntarily consents to participate in the study
Exclusion Criteria:
\-
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01717768
Study Brief:
Protocol Section:
NCT01717768