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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT03183102
Eligibility Criteria:
Inclusion Criteria:
* healthy premenopausal women (20-40 years)
* normal to overweight (22-29.9 kg/m2)
* normally menstruating (25-35 day cycles)
* not have used estrogen-based contraception for \>6 months.
* sedentary to moderately active (exercise ≤120 min week-1)
* must not be taking phytoestrogenic dietary supplements, or lipid- or glucose- lowering medications.
Exclusion Criteria:
* smoking
* pregnancy or breastfeeding
* Hormonal contraceptive use (past 6 mo.)
* Women with contraindications to GnRHAG:
* History of fragility fracture
* Low BMD (i.e., proximal femur or lumbar spine z scores \< -2.0)
* Abnormal vaginal bleeding
* History of breast cancer or other estrogen-dependent neoplasms
* History of venous thromboembolic events
* Hypersensitivity to leuprolide acetate or benzyl alcohol (the vehicle for injection of leuprolide acetate)
* Evidence for depressive symptoms (Score ≥ 18 on the Beck Depression Inventory, BDI)
* Moderate or severe renal impairment defined as a calculated creatinine clearance \<50 mL/min based on the equation of Cockcroft and Gault91
* Chronic hepatobiliary disease, conservatively defined as liver function tests (AST, ALT, alkaline phosphatase, Total Bilirubin) \>1.5 times the upper limit of normal (if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed)
* antibiotic or probiotic use within 2 months of sample collection
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT03183102
Study Brief:
Protocol Section:
NCT03183102