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

October 24, 2022 updated by: Hui-Hsuan Lau, Mackay Memorial Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Menopause for one year Age above 45 with symptoms of GSM

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: 2022/8/10-2024/2/28
Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
2022/8/10-2024/2/28
Vaginal health index score (VHIS)
Time Frame: 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
2022/8/10-2024/2/28
Female Sexual Function Index (FSFI)
Time Frame: 2022/8/10-2024/2/28
A brief multidimensional scale for assessing sexual function in women.
2022/8/10-2024/2/28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 28, 2022

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19MMHIS340e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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