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

NCT05483634 | Not Yet Recruiting FDA Drug

• 1 other identifier: 19MMHIS340e
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Visual analogue scale (VAS)

  Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria

  2022/8/10-2024/2/28

• 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

  2022/8/10-2024/2/28

• Female Sexual Function Index (FSFI)

  A brief multidimensional scale for assessing sexual function in women.

  2022/8/10-2024/2/28

Study Arms (1)

Genital urinary symptoms of menopause

Menopause for one year, or age above 45 with symptoms of GSM

Drug: Vaginal estrogen supplement; Procedure: Platelet-rich plasma injection

Interventions

Vaginal estrogen supplement DRUG

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

Genital urinary symptoms of menopause

Platelet-rich plasma injection PROCEDURE

Monthly platelet-rich plasma injection for three months

Genital urinary symptoms of menopause

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Menopause for one year Age above 45 with symptoms of GSM

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, 104, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 27472999 BACKGROUND

• 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.

  PMID: 28778337 BACKGROUND

• 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.

  PMID: 30103082 BACKGROUND

• 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.

  PMID: 30798700 BACKGROUND

• 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.

  PMID: 35194935 BACKGROUND

Study Officials

• Hui-Hsuan Lau

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Hsuan Lau

CONTACT

+886-25433535; huihsuan1220@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

TW (1)