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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01070160
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal between 18-42 years of age
* Diagnosed with PCOS as defined by chronic oligo- or amenorrhea (8 menstrual periods annually); biochemical hyperandrogenemia (elevated total or free testosterone) and /or clinical hyperandrogenism (excessive facial hair \&/or acne); exclusion of common medical disorders (normal thyroid function tests and serum prolactin and exclusion of 21-hydroxylase deficiency by a fasting 17-hydroxyprogesterone \<200 ng/dl).
* Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months
* Able to provide signed informed consent
* Able to comply with study requirements
* Willing to delay the start of clinically prescribed metformin treatment
Exclusion Criteria:
* Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)
* Current use of hormonal contraceptives
* Seeking pregnancy; use of fertility drugs within 6 months of study
* Current or recent (within 3 months) use of metformin
* Ingestion of any investigational drug within two months prior to study onset
* Evidence of endometrial hyperplasia or cancer upon baseline EMBx
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT01070160
Study Brief:
Protocol Section:
NCT01070160