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

NCT06808347 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: WRNMMC-2023-0432
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Postmenopausal Atrophic Vaginitis; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

vaginal estrogen application in post-menopausal women by fingertip use

ACTIVE COMPARATOR

will include post-menopausal women who are applying the vaginal estrogen cream by using their fingertip

Drug: application of the vaginal estrogen cream

vaginal estrogen application in post-menopausal women by applicator use

ACTIVE COMPARATOR

will include post-menopausal women who are applying the vaginal estrogen cream by using the applicator

Drug: application of the vaginal estrogen cream

Interventions

application of the vaginal estrogen cream DRUG

patients will apply the vaginal estrogen cream

vaginal estrogen application in post-menopausal women by applicator use; vaginal estrogen application in post-menopausal women by fingertip use

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Sara Hamade, MD

CONTACT

301 400 2468; sara.j.hamade.vol@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 5, 2025
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE