Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
NCT ID: NCT05483634
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-12-01
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Genital urinary symptoms of menopause
Menopause for one year, or age above 45 with symptoms of GSM
Vaginal estrogen supplement
Daily vaginal estrogen supplement, then twice per week. Continue for three months.
Platelet-rich plasma injection
Monthly platelet-rich plasma injection for three months
Interventions
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Vaginal estrogen supplement
Daily vaginal estrogen supplement, then twice per week. Continue for three months.
Platelet-rich plasma injection
Monthly platelet-rich plasma injection for three months
Eligibility Criteria
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Inclusion Criteria
* Patients with symptoms of genitourinary syndrome of menopause
Exclusion Criteria
* 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
45 Years
80 Years
FEMALE
No
Sponsors
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Mackay Memorial Hospital
OTHER
Responsible Party
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Hui-Hsuan Lau, MD
Doctor
Principal Investigators
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Hui-Hsuan Lau
Role: PRINCIPAL_INVESTIGATOR
Mackay Memorial Hospital
Locations
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MacKay Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.
Pitsouni E, Grigoriadis T, Douskos A, Kyriakidou M, Falagas ME, Athanasiou S. Efficacy of vaginal therapies alternative to vaginal estrogens on sexual function and orgasm of menopausal women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:45-56. doi: 10.1016/j.ejogrb.2018.08.008. Epub 2018 Aug 6.
Najjarzadeh M, Mohammad Alizadeh Charandabi S, Mohammadi M, Mirghafourvand M. Comparison of the effect of hyaluronic acid and estrogen on atrophic vaginitis in menopausal women: A systematic review. Post Reprod Health. 2019 Jun;25(2):100-108. doi: 10.1177/2053369119830818. Epub 2019 Feb 24. No abstract available.
Saleh DM, Abdelghani R. Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study. J Cosmet Dermatol. 2022 Oct;21(10):4269-4275. doi: 10.1111/jocd.14873. Epub 2022 Mar 7.
Other Identifiers
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19MMHIS340e
Identifier Type: -
Identifier Source: org_study_id
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