ACTIVE_NOT_RECRUITING

PRP Injections for Genitourinary Syndrome of Menopause

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06028009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
  2. * 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
  3. * English-speaking
  4. * Willingness and able to comply with the study requirements
  1. * Symptomatic pelvic organ prolapse protruding beyond the hymen)
  2. * History of prior vaginal mesh or midurethral mesh sling surgery
  3. * History of pelvic radiation or genital tract malignancy
  4. * Current symptomatic pelvic organ prolapse (stage II or greater)
  5. * Active vulvar dermatoses or genitourinary infection
  6. * Unable to hold anticoagulation
  7. * Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation
  8. * Pregnancy or pre-menopausal status

Contacts and Locations

Study Locations (Sites)

MedStar Lafayette Medical Centre
Washington D.C., District of Columbia, 20036
United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

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