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

NCT ID: NCT05483634

Last Updated: 2025-05-09

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Menopause Platelet-rich Plasma Estrogen Replacement Therapy Vaginal Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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

Platelet-rich plasma injection

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Platelet-rich plasma injection

Monthly platelet-rich plasma injection for three months

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hui-Hsuan Lau, MD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Taiwan

Central Contacts

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Hui-Hsuan Lau

Role: CONTACT

+886-25433535

Facility Contacts

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Hui-Hsuan Lau, MD

Role: primary

+88625433535

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.

Reference Type BACKGROUND
PMID: 27472999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28778337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30103082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30798700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35194935 (View on PubMed)

Other Identifiers

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19MMHIS340e

Identifier Type: -

Identifier Source: org_study_id

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