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

Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05483634
Enrollment
40
Registered
2022-08-02
Start date
2025-12-01
Completion date
2027-06-30
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Platelet-rich Plasma, Estrogen Replacement Therapy, Vaginal Atrophy

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.

Interventions

DRUGVaginal estrogen supplement

Daily vaginal estrogen supplement, then twice per week. Continue for three months.

Monthly platelet-rich plasma injection for three months

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Female Sexual Function Index (FSFI)2022/8/10-2024/2/28A brief multidimensional scale for assessing sexual function in women.
Visual analogue scale (VAS)2022/8/10-2024/2/28Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
Vaginal health index score (VHIS)2022/8/10-2024/2/28One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration

Countries

Taiwan

Contacts

Primary ContactHui-Hsuan Lau
huihsuan1220@gmail.com+886-25433535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026