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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT00927095
Eligibility Criteria:
Inclusion Criteria:
* meets prospective criteria for PMDD, AND
* English speaking and reading skills.
Exclusion Criteria:
* current psychiatric disorder other than PMDD,
* history of venous thromboembolism,
* over 35 years of age and obese,
* uncontrolled hypertension or end-organ vascular disease,
* diabetes,
* migraine headache with aura,
* breastfeeding or pregnant,
* cigarette smoking,
* family history of premenopausal breast cancer or breast cancer in more than one first degree relative,
* elevated serum potassium levels, use of prescription medications (except stable thyroid supplementation),
* irregular menstrual cycles, OR
* history of: endometriosis, hepatic disease, breast carcinoma, pulmonary embolism or phlebothrombosis, malignant melanoma, cholecystitis or pancreatitis.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
52 Years
Study:
NCT00927095
Study Brief:
Protocol Section:
NCT00927095