Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women

Describe step-by-step how the study will be conducted from beginning to end All women who are over the age of 18 who meet criteria for post-menopausal state, with symptoms of genitourinary syndrome of menopause, who qualify for local vaginal estrogen therapy and who are receiving care at Walter Reed National Military Medical Center (WRNMMC) in the Gynecological Surgery and Obstetrics department clinic will be eligible for the study.

All study participants will undergo a complete intake assessment to include a history, medication reconciliation, allergies verification, physical exam, and counseling on treatment modalities for genitourinary syndrome of menopause to include lubrication, vaginal moisturizers, non-hormonal treatments, vaginal estrogen treatment and laser therapy. The AUGS handout about vaginal estrogen therapy will be given to patients. Patients desiring treatment with vaginal estrogen therapy and meeting our inclusion and exclusion criteria will be offered enrollment in this study.

Enrollment will be done by the research team consisting of the clinician. No patient will be pressured or coerced into participating in the study. During the enrollment visit, participants will be consented for participation in the study and asked to complete a demographics data sheet and a female sexual function index questionnaire.

The statistician will make randomized assignments which will be concealed in sequentially numbered opaque envelopes which will be opened on the day of enrollment by the treatment provider. The envelop will reveal the method of application of the vaginal estrogen cream (applicator vs fingertip application). The provider will then reveal the allocation treatment group to the patient. The vaginal estradiol cream Estrace (chosen due to lower cost than other vaginal estrogen formulations) will then be provided to the patient. If the patient is allocated to the applicator group, a demonstration of the application will be completed in clinic using a vaginal model and a sample applicator. If the patient is allocated to the fingertip application, a demonstration of the application will be completed in clinic using a vaginal model. Printed information about each method of application will be provided to patients in both groups. Serum estrogen level will be drawn in the lab during this visit as a baseline measure for future comparison (the patient will be sent to the lab for the serum estrogen level to be drawn).

Standard of care treatment: 0.5g of the vaginal estrogen cream is inserted using the applicator into the vagina once a day for 2 weeks, followed by 3 times per week.