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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00816556
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women (no menses for the previous 12 months)
* Dryness, itching or burning in and around the vagina
* Discontinued hormone replacement therapy (either local or systemic) at least 3 months
Exclusion Criteria:
* Known, suspected, or history of cancer of the breast.
* Known, or suspected estrogen dependent neoplasia (ovarian, endometrial).
* Known hypersensitivity to any component of the medications or base creams.
* Active deep vein thrombosis, pulmonary embolism, or history of these conditions.
* Active or recent (within the past year) arterial thromboembolic disease (stroke, myocardial infarct).
* Liver dysfunction or disease with elevation of aspartate aminotransferase (AST)\>1.5x upper level of normal (ULN); Normal for females is 8-43 U/L.
* Undiagnosed abnormal genital bleeding.
* Known chronic lichen sclerosis.
* Known, untreated vaginal infection.
* Not had a normal screening mammogram within the last 15 months.
* Hysterectomy without oophorectomy unless 60 years or older.
* Women taking aromatase inhibitors or tamoxifen.
* Hgb \<12.0 or \>15.5 g/dL
* Urinalysis showing a urinary tract infection (UTI).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00816556
Study Brief:
Protocol Section:
NCT00816556