PRP Injections for Genitourinary Syndrome of Menopause

Last updated: May 13, 2025
Sponsor: Medstar Health Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginitis

Vaginal Atrophy

Treatment

Injection of platelet-rich plasma

Injection of saline

Clinical Study ID

NCT06028009
STUDY00006805
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women (assigned female at birth) at least 18 years old with a clinical diagnosis ofGSM

  • Sexually active with at least one episode of sexual activity per week in thepreceding 4 weeks defined as follows: Partnered or solo penetrative ornon-penetrative stimulation of the clitoris or vagina

  • English-speaking

  • Willingness and able to comply with the study requirements

Exclusion

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 ofparticipation

  • Pregnancy or pre-menopausal status

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Injection of platelet-rich plasma
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • MedStar Lafayette Medical Centre

    Washington, District of Columbia 20036
    United States

    Active - Recruiting

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