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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-80
SponsorMackay Memorial Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Women with menopause

Patients with symptoms of genitourinary syndrome of menopause

Disqualifiers

Genitourinary bleeding or infection without definitive diagnosis

Coagulopathy

Allergy to medication or therapy related with the treatment

Chronic disease that might influence outcome

Trial population

Menopause for one year Age above 45 with symptoms of GSM

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Vaginal estrogen supplement

    Drug

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

  • Platelet-rich plasma injection

    Procedure/Surgery

    Monthly platelet-rich plasma injection for three months

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Genital urinary symptoms of menopause2 interventions

Trial outcomes

Primary outcomes

1

Visual analogue scale (VAS)

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

Time frame
2022/8/10-2024/2/28
2

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

Time frame
2022/8/10-2024/2/28
3

Female Sexual Function Index (FSFI)

A brief multidimensional scale for assessing sexual function in women.

Time frame
2022/8/10-2024/2/28

Secondary outcomes

Other outcomes

Sponsors and contacts

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