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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT01457703
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-40 at study entry
* BMI either 18-25 kg/m2 or ≥30 kg/m2
* prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
* Baseline hemoglobin \>11 gm/dl
* History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2
Exclusion Criteria:
* History of chronic disease affecting hormone production, metabolism or clearance
* Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)
* Use of hormones within three months of enrollment
* Excessive exercise (\>4 hours per week)
* Pregnancy, breast-feeding or current active attempts to conceive
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01457703
Study Brief:
Protocol Section:
NCT01457703