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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571527 on ClinicalTrials.gov