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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT07077395
Eligibility Criteria:
Inclusion Criteria:
* Age 40-65 years
* Peri- and post-menopausal women (STRAW -1 to +1)
* Moderate or high vasmotor symptom burden
* Cardiometabolic disease (as evidenced by ≥ 2 of the following):
* Obesity (body mass index ≥ 30 kg/m2)
* Elevated waist circumference (≥ 88 cm)
* Elevated triglycerides (≥ 150 mg/dL or drug treatment)
* Reduced HDL-cholesterol (\<50 mg/dL or drug treatment)
* Elevated blood pressure (≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure, or drug treatment)
* Elevated fasting glucose (≥ 100 mg/dL or drug treatment)
Exclusion Criteria:
* Inability to provide informed consent or comply with study protocol
* Major comorbidities: cancer, end-stage renal (eGFR \<45 mL/min/1.73 m2), liver or lung disease
* Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors
* Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)
* Undiagnosed uterine bleeding over past 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07077395
Study Brief:
Protocol Section:
NCT07077395