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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVE: To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome SECONDARY OBJECTIVE: To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments. OUTLINE: Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes After 3 sessions of PRP treatment, patients are followed up for 6 months. ;


Study Design


Related Conditions & MeSH terms

  • Genitourinary Syndrome of Menopause
  • Syndrome

NCT number NCT05571527
Study type Interventional
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact Ozan Karadeniz, MD
Phone +905333663003
Email dr.ozankrdnz@gmail.com
Status Recruiting
Phase N/A
Start date November 1, 2023
Completion date December 1, 2024

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