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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT03996603
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal with vulvovaginal atrophy
* Age ≥55 years old and a screening vaginal pH of ≥5.
* Without menses for ≥12 months.
* No uterovaginal or vaginal vault prolapse beyond the hymen.
* No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
Exclusion Criteria:
* Patients with BMI \>35kg/m2
* Any patients with infections requiring antibiotic or antifungal therapy during the study period.
* Study patients may not use any vaginal suppositories, douches, or vaginal hygiene wipes within the month preceding enrollment. For patients already on hormone therapy, will be allowed to undergo a "wash out" period of estrogen or progesterone products for one month prior to enrollment.
* Additional exclusions included patients with systemic conditions requiring immunosuppressive drugs, currently receiving chemotherapy, or history of pelvic radiation.
* Any patients with contraindications to vaginal estrogen therapy including: vaginal bleeding of unknown etiology; known, suspected, or history of breast cancer or estrogen-dependent neoplasia; active DVT, PE, or h/o these conditions; active arterial thromboembolic disease (ie. stroke or MI) or h/o of these; known liver disease or thrombophilic disorders.
* Current tobacco use.
* Allergy to Premarin® or its constituents.
* Concurrent use of steroid creams for other indications (ie. lichen sclerosis)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
55 Years
Study:
NCT03996603
Study Brief:
Protocol Section:
NCT03996603