PRP Injections for Genitourinary Syndrome of Menopause

NCT06028009 | Active Not Recruiting

• 1 other identifier: STUDY00006805
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index

  Validated questionnaire to assess domains of sexual function with range from 2 to 36 with lower score indicating worse sexual functioning (diagnostic for sexual dysfunction if score is less than or equal to 26.55)

  Assessed at baseline and at 6 weeks and 6 months post-procedure

Secondary Outcomes (3)

• Patient Global Impression of Improvement (PGI-I)

  Assessed at 6 weeks and 6 months post-intervention

• Visual analog scale for vaginal dryness (VAS)

  Assessed at 6 weeks and 6 months post-intervention

• Urinary Distress Inventory (short form) (UDI-6)

  Assessed at baseline and 6 weeks/6 months post-intervention

Study Arms (2)

Platelet-rich plasma injection

EXPERIMENTAL

Procedure: Injection of platelet-rich plasma

0.9% saline injection

SHAM COMPARATOR

Procedure: Injection of saline

Interventions

Injection of platelet-rich plasma PROCEDURE

Injection of autologous platelet-rich plasma into anterior vaginal wall

Platelet-rich plasma injection

Injection of saline PROCEDURE

Injection of sterile normal saline into anterior vaginal wall

0.9% saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Lafayette Medical Centre

Washington D.C., District of Columbia, 20036, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)