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

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05483634
Collaborator
(none)
40
Enrollment
29
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vaginal estrogen supplement
  • Procedure: Platelet-rich plasma injection

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Genital urinary symptoms of menopause

Menopause for one year, or age above 45 with symptoms of GSM

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

Outcome Measures

Primary Outcome Measures

  1. Visual analogue scale (VAS) [2022/8/10-2024/2/28]

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

  2. Vaginal health index score (VHIS) [2022/8/10-2024/2/28]

    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

  3. Female Sexual Function Index (FSFI) [2022/8/10-2024/2/28]

    A brief multidimensional scale for assessing sexual function in women.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mackay Memorial Hospital

Investigators

  • Principal Investigator: Hui-Hsuan Lau, Mackay Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hui-Hsuan Lau, Doctor, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05483634
Other Study ID Numbers:
  • 19MMHIS340e
First Posted:
Aug 2, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Estrogens

Study Results

No Results Posted as of Aug 5, 2022