About this trial
The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with menopause
Patients with symptoms of genitourinary syndrome of menopause
Disqualifiers
Genitourinary bleeding or infection without definitive diagnosis
Coagulopathy
Allergy to medication or therapy related with the treatment
Chronic disease that might influence outcome
Trial population
Menopause for one year Age above 45 with symptoms of GSM
Trial design
Cohort
Prospective
Treatments tested in this trial
Vaginal estrogen supplement
DrugDaily vaginal estrogen supplement, then twice per week. Continue for three months.
Platelet-rich plasma injection
Procedure/SurgeryMonthly platelet-rich plasma injection for three months
Treatment groups
Trial outcomes
Primary outcomes
Visual analogue scale (VAS)
Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
Vaginal health index score (VHIS)
One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
Female Sexual Function Index (FSFI)
A brief multidimensional scale for assessing sexual function in women.
Sponsors and contacts
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