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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01562834
Eligibility Criteria:
Inclusion Criteria:
* Childhood or adult onset growth hormone deficiency (GHD)
* GHD evidenced by two stimulation tests
* Duration of GHD at least 5 years
* Other hormone deficiencies associated with growth hormone deficiency
Exclusion Criteria:
* Pregnancy or pregnancy desired during the suggested duration of the study
* Personal history of colonic polyp or family history of colonic polyposis
* Known insulin-dependent or non-insulin-dependent diabetes
* Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
* BMI (Body Mass Index) at least 30
* Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
* Patient who has participated in a different clinical study within the past two months
* Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
* Notion of breast cancer for the mother or the sister
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01562834
Study Brief:
Protocol Section:
NCT01562834