A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause
NCT05812924 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-05-13
Summary
The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.
Conditions
- Breast Cancer
- Genitourinary Syndrome of Menopause
Interventions
- BIOLOGICAL
-
Platelet-rich plasma (PRP)
0.1-0.2 mL injections of platelet-rich plasma (PRP) will be injected to the vulvovaginal area. The injections will be placed every 5mm and at an angle of 60° into the mucosa and lamina propria of the posterior wall of the vagina.
Sponsors & Collaborators
-
University of Miami
lead OTHER
Principal Investigators
-
Abdulrahman Sinno, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-26
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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