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Active Not RecruitingNCT06028009

PRP Injections for Genitourinary Syndrome of Menopause

Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Medstar Health Research Institute · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.

Conditions

Interventions

TypeNameDescription
PROCEDUREInjection of platelet-rich plasmaInjection of autologous platelet-rich plasma into anterior vaginal wall
PROCEDUREInjection of salineInjection of sterile normal saline into anterior vaginal wall

Timeline

Start date
2024-03-01
Primary completion
2025-12-31
Completion
2026-04-30
First posted
2023-09-07
Last updated
2025-11-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06028009. Inclusion in this directory is not an endorsement.