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PRP Injections for Genitourinary Syndrome of Menopause

NCT ID: NCT06028009

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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PRP Sexual Function Disturbances Genitourinary Syndrome of Menopause Postmenopausal Symptoms Vaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Platelet-rich plasma injection

Group Type EXPERIMENTAL

Injection of platelet-rich plasma

Intervention Type PROCEDURE

Injection of autologous platelet-rich plasma into anterior vaginal wall

0.9% saline injection

Group Type SHAM_COMPARATOR

Injection of saline

Intervention Type PROCEDURE

Injection of sterile normal saline into anterior vaginal wall

Interventions

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Injection of platelet-rich plasma

Injection of autologous platelet-rich plasma into anterior vaginal wall

Intervention Type PROCEDURE

Injection of saline

Injection of sterile normal saline into anterior vaginal wall

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
* Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina
* English-speaking
* Willingness and able to comply with the study requirements

Exclusion Criteria

* Symptomatic pelvic organ prolapse protruding beyond the hymen)
* History of prior vaginal mesh or midurethral mesh sling surgery
* History of pelvic radiation or genital tract malignancy
* Current symptomatic pelvic organ prolapse (stage II or greater)
* Active vulvar dermatoses or genitourinary infection
* Unable to hold anticoagulation
* Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation
* Pregnancy or pre-menopausal status
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MedStar Lafayette Medical Centre

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00006805

Identifier Type: -

Identifier Source: org_study_id