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

Study the change in serum estrogen level based on the method of vaginal cream application (applicator vs fingertip application) and Measure patient satisfaction with vaginal estrogen cream application based on the method of application using a validated patient questionnaire (Likert scale).

Study Overview

• Status: Not yet recruiting
• Conditions: Postmenopausal Atrophic Vaginitis; Genitourinary Syndrome of Menopause
• Intervention / Treatment: Drug: application of the vaginal estrogen cream

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sara Hamade, MD; Phone Number: 301 400 2468; Email: sara.j.hamade.vol@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients who are postmenopausal for at least 1 year (since their last menses)
• patients who qualify for treatment with vaginal estrogen cream and are willing to complete the treatment
• English speaking patients
• patients should be able to self-apply the vaginal estrogen cream using the applicator method and the fingertip application
• Patients who are surgically menopausal
• Military healthcare beneficiary status

Exclusion Criteria:

• pre and perimenopausal women
• contraindication to estrogen therapy (Deep vein thrombosis, history or active cancer)
• women who are not able to self apply the vaginal estrogen cream
• vaginal bleeding of unknown origin
• women currently on hormone replacement therapy or vaginal estrogen therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vaginal estrogen application in post-menopausal women by fingertip use; will include post-menopausal women who are applying the vaginal estrogen cream by using their fingertip	Drug: application of the vaginal estrogen cream; patients will apply the vaginal estrogen cream
Active Comparator: vaginal estrogen application in post-menopausal women by applicator use; will include post-menopausal women who are applying the vaginal estrogen cream by using the applicator	Drug: application of the vaginal estrogen cream; patients will apply the vaginal estrogen cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the change in the level of serum estrogen in postmenopausal women based on the method of application of the estrogen cream (fingertip vs applicator use).	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure patient satisfaction with vaginal estrogen cream application based on the method of application using a validated patient questionnaire (Likert scale).	6-8 weeks
Measure improvement in sexual dysfunction with application of the vaginal estrogen cream based on the method of application using a validated patient questionnaire (Female sexual function index).	6-8 weeks

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vaginal Diseases; Vaginitis; Atrophic Vaginitis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens
• Other Study ID Numbers: WRNMMC-2023-0432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No