Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause

Not yet recruiting

• Conditions: Menopause; Platelet-rich Plasma; Vaginal Atrophy; Estrogen Replacement Therapy
• Interventions: Drug: Vaginal estrogen supplement; Procedure: Platelet-rich plasma injection

• Registration Number: NCT05483634
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-07-31
• Study First Posted: 2022-08-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-12-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women with menopause
• Patients with symptoms of genitourinary syndrome of menopause

Exclusion Criteria

• Genitourinary bleeding or infection without definitive diagnosis
• Coagulopathy
• Allergy to medication or therapy related with the treatment
• Chronic disease that might influence outcome
• Using medication that might influence outcome in 30 days
• Using hormone or steroid within 8 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genital urinary symptoms of menopause	Vaginal estrogen supplement	Menopause for one year, or age above 45 with symptoms of GSM
Genital urinary symptoms of menopause	Platelet-rich plasma injection	Menopause for one year, or age above 45 with symptoms of GSM

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI)	2022/8/10-2024/2/28	A brief multidimensional scale for assessing sexual function in women.
Visual analogue scale (VAS)	2022/8/10-2024/2/28	Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
Vaginal health index score (VHIS)	2022/8/10-2024/2/28	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

Trial Locations

Locations (1)

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan