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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT01899612
Eligibility Criteria:
Inclusion Criteria:
* Age of 40 years or older
* At least 1 year history of amenorrhea
* Normal Pap smear within the past year
* Willingness to abstain from sexual intercourse and use of over-the-counter vaginal products for 7 days before the collection of vaginal samples
* Written informed consent.
Exclusion Criteria
* Administration of any form of oral hormone replacement therapy within 2 months, transdermal or vaginal hormone replacement therapy for 1 months prior to entry into the study
* Active vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis based on vaginal wet prep, pH, whiff test and KOH preparation;
* Untreated cervical, vaginal or vulvar intraepithelial neoplasia;
* Active sexually transmitted diseases including herpes simplex viral infection, gonorrhea and Chlamydia
* Pessary-users
* Active treatment with tamoxifen, raloxifene or other forms of selective estrogen receptor modulators (SERMs);
* Undiagnosed vaginal bleeding
* Hysterectomy
* Past or current history breast cancer, endometrial cancer or endometrial hyperplasia, hypertriglyceridemia or venous thromboembolism
* Immunocompromised patient including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT01899612
Study Brief:
Protocol Section:
NCT01899612