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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT02458404
Eligibility Criteria:
Inclusion Criteria:
* Regular menstrual cycles
* Age 18-50
* Normal Baseline ultrasound
* No intra-uterine procedures in prior 90 days
Exclusion Criteria:
* Any contraindications to undergoing estrogen stimulation of the endometrium
* Age ≥35 years and smoking ≥15 cigarettes per day
* Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and hypertension)
* Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
* Venous thromboembolism (current or history of)
* Known thrombogenic mutations
* Known ischemic heart disease
* History of stroke
* Complicated valvular heart disease (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis)
* Systemic lupus erythematosus (positive or unknown antiphospholipid antibodies)
* Migraine with aura at any age
* Breast cancer
* Cirrhosis
* Hepatocellular adenoma or malignant hepatoma
* History of undiagnosed abnormal uterine bleeding.
* Allergic reaction to any study drug
* Known pregnancy or delivery within the past 6 months
* Breastfeeding
* Obesity \>35 kg/m2
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02458404
Study Brief:
Protocol Section:
NCT02458404