Clinical trial NCT05483634: Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Official title: Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Menopause
Platelet-rich Plasma
Estrogen Replacement Therapy
Vaginal Atrophy
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Menopause for one year Age above 45 with symptoms of GSM

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 2022/8/10-2024/2/28
measure: Vaginal health index score (VHIS)
timeFrame: 2022/8/10-2024/2/28
measure: Female Sexual Function Index (FSFI)
timeFrame: 2022/8/10-2024/2/28
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Hui-Hsuan Lau
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. No abstract available.
citation: 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.