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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT01169103
Eligibility Criteria:
Inclusion Criteria:
* Adolescent girls 13-21 years old with bone age ≥ 14 years
* Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age
* Waist/Hip ratio ≥ 0.85
* Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal stage or age
Exclusion Criteria:
* Pregnancy (positive pregnancy test) prior to enrollment in the study
* Significant weight gain or loss within 3 months of study (more than 5 kg)
* Use of medications that affect GH or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids)
* Use of medications such as Meridian and Orlistat
* Presence of diabetes mellitus
* Uncontrolled Thyroid disorders
* Chronic renal insufficiency
* Participation in another simultaneous medical investigation or trial
* Active neoplasm or history of cancer
* Prader-Willi syndrome
* History of scoliosis if bone age is \<15 years
* Hypersensitivity to rhGH or constituents of the injections
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
21 Years
Study:
NCT01169103
Study Brief:
Protocol Section:
NCT01169103