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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00518635
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Age 21 to 45 years
* Body mass index between 30 to 40 kg/m2
* Diagnosis of PCOS with underlying insulin resistance (assessed by HOMA at screening visit) and/or other features that characterizes the metabolic syndrome such as hypertension ( \> 130/85 mmHg), abdominal obesity (waist circumference \> 88 cm), and acanthosis nigricans
* Diagnosis of normal or impaired glucose tolerance (WHO criteria)
* Stable body weight for at least 6 months prior to study entry (body weight deviating +/- 5 kg from previously recorded weight \> 6 months ago)
* Normal thyroid, renal and hepatic function
* Able to self administer daily GH/Placebo injections
Exclusion Criteria:
* Inability to comply with study requirements
* Body mass index \< 30 kg/m2 and \> 40 kg/m2 (patients with body mass index \> 40 kg/m2 are excluded because they will not fit into the MRS scanner)
* Untreated hypothyroidism or hyperthyroidism
* Anemia from any cause
* Known diabetes mellitus
* Patients with an increased risk of venous thrombosis or previous history of recurrent venous thrombosis
* Patient on any insulin-sensitizers (e.g., Metformin, Rosiglitazone, Pioglitazone) within 30 days of screening assessment
* Patient on any anti-androgens (e.g., Spironolactone, Cyproterone acetate, Flutamide, Finasteride) within 30 days of screening assessment
* Patient with other concurrent illnesses
* Pregnant (positive pregnancy test) prior enrollment in the study or planning to conceive whilst participating in the study
* Emotional/social instability likely to prejudice study completion
* Previous history of known malignancy
* Recurrent or severe unexplained hypoglycemia
* Known or suspected drug/alcohol abuse
* Patient with any metals in the body
* Any other condition/s that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT00518635
Study Brief:
Protocol Section:
NCT00518635