Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
NCT05571527 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-03-05
Summary
Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients.
Platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. The blood is spun using a centrifuge that separates the plasma and red blood cells.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. The observational cohort study will be used for the study design. Questionnaires, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used to evaluate the effectiveness and side effects.
Conditions
- Genitourinary Syndrome of Menopause
Interventions
- BIOLOGICAL
-
Platelet Rich Plasma treatment
Patients receive platelet-rich plasma via injection into the vaginal area.
- DRUG
-
Vaginal Hyaluronic Acid supplement
Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months.
Sponsors & Collaborators
-
Kanuni Sultan Suleyman Training and Research Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2024-03-01
- Completion
- 2024-12-01
Countries
- Turkey (Türkiye)
Study Locations
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