PRP Injections for Genitourinary Syndrome of Menopause

What this trial studies

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 in scope

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

Interventions

• 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

Who can join

Women only · Ages 18 Years and up

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-03-01
• Primary completion: 2025-12-31
• Last update posted: 2025-11-14
• First posted: 2023-09-07

Sponsor & contact

Lead sponsor: Medstar Health Research Institute (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Female Sexual Function Index (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)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.