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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02730169
Eligibility Criteria:
Inclusion Criteria:
* Adult male subject aged 18 to 65 years inclusive
* BMI \> 30 kg/m2 and \< 50 kg/m2
* Serum total testosterone concentration below the normal range
* LH levels below the upper limit of normal
* Oestradiol levels within or above the normal range of approved assay
* At least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunction
Exclusion Criteria:
* Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
* Other types of hypogonadotropic hypogonadism or primary hypogonadism
* Any other pituitary or hypothalamic disease
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02730169
Study Brief:
Protocol Section:
NCT02730169