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PRP for Genitourinary Syndrome of Menopause in Breast Cancer Survivors
NCT05812924Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2023
- Primary completion
- Sep 2026
- Countries
- 1
- Sponsor
- University of Miami
- Modality
- Adipose-derived MSCs, Bone Marrow MSCs
- Drugs
- platelet-rich plasma
- Conditions
- genitourinary syndrome of menopause (GSM)
01
Overview
Phase 2, open-label, single-arm trial of platelet-rich plasma in genitourinary syndrome of menopause (GSM), sponsored by University of Miami. Primary endpoint: Vulvovaginal Symptom Questionnaire at 31 weeks. Started Sep 2023; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Platelet-rich plasma (PRP) Group
Participants will undergo two sessions of platelet-rich plasma (PRP) injections to the vulva/vagina one month apart.
03
Who it enrols
Female breast cancer or DCIS survivors (Stage I-III) with Genitourinary Syndrome of Menopause (VHI < 15), excluding those on recent HRT, anticoagulants, or with genital infections.
04
Endpoints
Primary
Vulvovaginal Symptom Questionnaire
Secondary
Vaginal Health Index
Female Sexual Function Index
Female Sexual Distress Scale-Revised
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