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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT00136032
Eligibility Criteria:
Inclusion Criteria:
* GH deficiency due to pituitary or hypothalamic tumors or disease affecting this area. Subjects will have been treated with medication, surgery, radiation, or a combination of these. GH deficiency will be defined as a peak plasma GH of less than 5 ng/ml in response to insulin tolerance testing or growth hormone releasing hormone (GHRH) plus arginine stimulation test. In subjects with suspected hypothalamic dysfunction the arginine plus L-dopa stimulation test may be used, with a cutoff of 1.7 ng/ml for diagnosis of GH deficiency. Partial GH deficiency will be defined as a GH peak of 5 to 9 ng/ml (inclusive) during insulin tolerance testing or GHRH plus arginine testing.
* GH deficiency will also be diagnosed if insulin-like growth factor-I (IGF-I) levels are below 2 standard deviations for the age-sex normal range in a patient with at least two documented hormone deficiencies.
* Subjects must have evidence of a stable pituitary mass (for at least 12 months) if there is a history of a tumor except in the case of ACTH-producing microadenomas, where no follow-up imaging is required after cure.
* Subjects age 40 and over must have a screening mammogram if they have not already had one within one year prior to their baseline visit
Exclusion Criteria:
* Active Cushing's disease within 1 year
* History of acromegaly
* Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study.
* History of malignancy except for skin cancer and except for childhood solid malignancy with documented cure for \> 10 years prior to starting the study
* Hemoglobin \<10.0 gm/dl
* Hepatic or renal disease (SGPT/SGOT \> 3x upper limit of normal (ULN) or creatinine levels \>2.5 mg/dl)
* Congestive heart failure (CHF) (New York Heart Association's classification system Class II-IV CHF will be excluded)
* History of unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
* Diabetes mellitus
* Pregnancy or nursing
* Active carpal tunnel syndrome
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00136032
Study Brief:
Protocol Section:
NCT00136032