PRP injections to improve sexual function in menopausal women
Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
This study is testing if PRP injections can help improve sexual function in menopausal women who are dealing with symptoms like vaginal dryness and irritation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medstar Health Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT06028009 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of platelet-rich plasma (PRP) injections in enhancing sexual function for women experiencing genitourinary syndrome of menopause (GSM). The study involves a single-blinded randomized control design where participants receive either PRP or saline injections into the anterior vaginal wall. The primary focus is on women who are sexually active and have been diagnosed with GSM, characterized by symptoms such as vaginal dryness and irritation. The trial aims to assess whether PRP can stimulate cell growth and improve sexual functioning in this population.
Who should consider this trial
Good fit: Ideal candidates are women assigned female at birth, aged 18 and older, who are sexually active and have a clinical diagnosis of GSM.
Not a fit: Patients with symptomatic pelvic organ prolapse, a history of certain surgeries, or those currently on hormonal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance sexual function and quality of life for menopausal women suffering from GSM.
How similar studies have performed: While the use of PRP for sexual dysfunction is relatively novel, there have been some patents and preliminary studies suggesting potential benefits, though comprehensive data is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington, District of Columbia
- MedStar Lafayette Medical Centre — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Neha G Gaddam, M.D.
- Email: neha.g.gaddam@medstar.net
- Phone: 8328650244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.