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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04189133
Eligibility Criteria:
Inclusion Criteria:
* Male sex
* Age between 18 and 45 years
* Acquired HH forms
* HH after neurosurgery for tumors (i.e. pituitary adenoma, including prolactinoma, craniopharyngioma, germinomas, meningiomas, gliomas, and astrocytomas). Infiltrative disease (hemochromatosis, granulomatous disease, histiocytosis, and sarcoidosis), OR
* HH due to pituitary adenoma-related mass effect, in case of cured or controlled hormone hypersecretion
* Total testosterone serum levels below the normal ranges (lower than 3 ng/mL)
* No androgen replacement therapies in the last three months before enrolment
* No hyper-secretion of other pituitary hormones
Exclusion Criteria:
HH forms, such as:
* Combined pituitary hormone deficiency
* Genetic syndromes (e.g., Prader-Labhart-Willi, CHARGE, Lawrence-Moon- Bardet-Biedl)
* Iatrogenic HH forms, such as traumatic pituitary stalk interruption syndrome, irradiation, high dose corticosteroids, and anabolic steroids
* Drug abuse and major systemic diseases
* Chronic severe liver disease
* Concomitant illnesses which could interfere with the study participation
* Active malignancy diseases
* Known or possible androgen-dependent tumors for example male breast carcinoma or prostatic carcinoma
* Cardiac failure, hypertension, renal dysfunction, migraines, or epilepsy. (since aggravation or recurrence may occasionally be induced as a result of increased androgen production)
* Haematocrit \<40% or \>54%
* Congenital HH are excluded since these genetic forms of HH could be related to other systemic or pituitary diseases, which could bias the selection of patients.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04189133
Study Brief:
Protocol Section:
NCT04189133