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NCT Number: NCT06028009

PRP Injections for Genitourinary Syndrome of Menopause

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

PRP Genitourinary Syndrome of Menopause Mental Disorders Postmenopausal Symptoms Sexual Dysfunctions, Psychological Sexual Function Disturbances Vaginal Atrophy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Lafayette Medical Centre

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of platelet-rich plasma

Procedure

Injection of autologous platelet-rich plasma into anterior vaginal wall

Injection of saline

Procedure

Injection of sterile normal saline into anterior vaginal wall

Primary outcomes

  1. Female Sexual Function Index

    Time frame: Assessed at baseline and at 6 weeks and 6 months post-procedure

    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)

Secondary outcomes

  1. Patient Global Impression of Improvement (PGI-I)

    Time frame: Assessed at 6 weeks and 6 months post-intervention

    Single item questionnaire evaluating improvement in vaginal dryness with scale from 1 to 7 with lower score indicating greater improvement in vaginal dryness

  2. Visual analog scale for vaginal dryness (VAS)

    Time frame: Assessed at 6 weeks and 6 months post-intervention

    Visual analog scale for vaginal dryness (VAS) with range from 0 to 10 with higher score indicating higher degree of bothersome vaginal dryness

  3. Urinary Distress Inventory (short form) (UDI-6)

    Time frame: Assessed at baseline and 6 weeks/6 months post-intervention

    6 item questionnaire assessing urinary symptoms with range from 0-18 with higher score indicating greater distress related to urinary symptoms

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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