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

Sponsor
Mackay Memorial Hospital
Study ID
NCT05483634
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Vaginal estrogen supplement — DRUG
    Daily vaginal estrogen supplement, then twice per week. Continue for three months.
  • Platelet-rich plasma injection — PROCEDURE
    Monthly platelet-rich plasma injection for three months

Study Details

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.

Key Dates

First listed
Aug 2, 2022
Start date
Dec 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Genital urinary symptoms of menopause
    Menopause for one year, or age above 45 with symptoms of GSM

Primary Outcome Measure

Visual analogue scale (VAS) [ Time Frame: 2022/8/10-2024/2/28 ]

Central Contacts

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