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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05483634
Other study ID # 19MMHIS340e
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 28, 2022
Est. completion date December 31, 2024

Study information

Verified date October 2022
Source Mackay Memorial Hospital
Contact Hui-Hsuan Lau
Phone +886-25433535
Email huihsuan1220@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 80 Years
Eligibility 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


Intervention

Drug:
Vaginal estrogen supplement
Daily vaginal estrogen supplement, then twice per week. Continue for three months.
Procedure:
Platelet-rich plasma injection
Monthly platelet-rich plasma injection for three months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mackay Memorial Hospital

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Saleh DM, Abdelghani R. Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study. J Cosmet Dermatol. 2022 Feb 23. doi: 10.1111/jocd.14873. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale (VAS) Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria 2022/8/10-2024/2/28
Primary 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
Primary Female Sexual Function Index (FSFI) A brief multidimensional scale for assessing sexual function in women. 2022/8/10-2024/2/28
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