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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
MedStar Lafayette Medical Centre
RECRUITING
Washington D.c.
Contact Information
Primary
Neha G Gaddam, M.D.
neha.g.gaddam@medstar.net
8328650244
Backup
Neha G Gaddam, M.D.
gaddam.ng@gmail.com
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Platelet-rich plasma injection
Sham_comparator: 0.9% saline injection
Related Therapeutic Areas
Sponsors
Leads: Medstar Health Research Institute

This content was sourced from clinicaltrials.gov