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.
The research component will be to insert a pea size amount of the estrogen cream into the
vagina using the index finger (finger application) once a day for 2 weeks, followed by 3
times per week.
The patient satisfaction questionnaires, blood draws to check the serum estrogen levels,
and the 6-10 week follow up visit are not standard of care and will be part of our
research component done for the purpose of this study. our research aims to study the
difference in serum estrogen level based on the method of application of the vaginal
estrogen cream: using the applicator ( which is standard of care) vs using fingertip
application of the cream into the vagina (research component).
Patients will be instructed to apply the vaginal estrogen cream daily for 2 weeks,
followed by 3 times per week for an additional 4-8 weeks (total 6-10 weeks). Patients
will be offered an in person follow up appointment at 6-10 weeks after starting the
vaginal estrogen cream. they can also be offered a virtual visit via telephone or
electronic health record patient portal. if they elect to have a virtual visit, they will
be asked to drop off their vaginal estrogen tube in a drop box in clinic for the tube to
be weighed for compliance and will also be asked to go to the lab to have their blood
drawn to check the serum estrogen level.
During the in-person follow up visit, the vaginal estradiol cream will be measured by
weighing the tube to confirm patient's compliance with the treatment. The patient will be
asked to complete a second female sexual function index questionnaire to compare to the
baseline questionnaire, as well as a Likert scale questionnaire to evaluate satisfaction
with the application method. Serum estrogen levels will be drawn again by having the
patient go to the lab to compare to baseline as well (to the initial serum level that was
drawn during the initial visit).
After study completion, patients are given the option to continue using the vaginal
estrogen cream indefinitely or to discontinue it if they are not satisfied with the
treatment.