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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00694759
Eligibility Criteria:
Inclusion Criteria (Healthy controls):
* Healthy
* At lifetime maximal weight
* Weight stable for at least 6 months prior to study entry
* Willing to commit to not making significant changes to their diet or daily activities while enrolled.
* Premenopausal
* Have regular menstrual cycles
* No evidence of hirsutism
Additional Inclusion Criteria (Subjects with PCOS):
* Clinical findings of amenorrhea or oligomenorrhea dating from menarche
* Clinical and/or biochemical evidence of hyperandrogenism
* Exclusion of related disorders
Exclusion Criteria (Healthy controls):
* Less than 18 years of age
* Exercise \> 30 minutes/day, 3 times a week
* Smokers
* Heavy alcohol drinkers (\> 2 drinks/day)
* Type 2 diabetes
* Medical diagnoses including heart disease and cancer
* Psychiatric illness (i.e.depression, psychosis, bipolar, schizophrenia)
* Body weight \> 136 kg
* Pregnant
* Endocrine diseases affecting body composition or androgen levels
Additional Exclusion Criteria (Subjects with PCOS):
* Laboratory evidence of hyperprolactinemia, thyroid dysfunction, or 21-hydroxylase-deficient nonclassic CAH
* Contraindication to pioglitazone (i.e. CHF, impaired liver function, anemia, depressed leukocyte counts, pulmonary disease, known sensitivity to thiazolidinediones.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00694759
Study Brief:
Protocol Section:
NCT00694759