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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05483634
• Other study ID #: 19MMHIS340e
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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