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 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT01753102
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal woman
* At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
* ≤ 5% superficial cells on vaginal smear cytology
* Vaginal pH \> 5.0
Exclusion Criteria:
* Consumption of estrogen alone or estrogen/progestin containing drug products.
* Allergy to estradiol or related products
* History of breast cancer and significant risk factors for endometrial cancer
* Abnormal genital bleeding
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01753102
Study Brief:
Protocol Section:
NCT01753102