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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT01483118
Eligibility Criteria:
Inclusion Criteria:
* Patients aged greater than 18 years of age
* Ability to understand and willingness to comply with the study protocol
* Written informed consent
* Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries.
Exclusion Criteria:
* Current pregnancy or lactation
* Liver disease or elevated liver enzymes
* Established diagnosis of diabetes mellitus
* Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association.
* Insulin sensitizing treatment within 3 months prior to or during the eight week study period.
* Hormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding.
* Systemic or inhaled corticosteroids.
* Known hypersensitive reaction to cinnamon.
* Patients with seizure disorders, known cardiovascular disease, or cerebrovascular disease.
* Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
38 Years
Study:
NCT01483118
Study Brief:
Protocol Section:
NCT01483118