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

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ClinicalTrials.gov Identifier: NCT05483634
Recruitment Status : Not yet recruiting
First Posted : August 2, 2022
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Hui-Hsuan Lau, Mackay Memorial Hospital

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
Menopause Platelet-rich Plasma Estrogen Replacement Therapy Vaginal Atrophy Drug: Vaginal estrogen supplement Procedure: Platelet-rich plasma injection

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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 27, 2022
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

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




Primary Outcome Measures :
  1. Visual analogue scale (VAS) [ Time Frame: 2022/8/10-2024/2/28 ]
    Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria

  2. 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

  3. Female Sexual Function Index (FSFI) [ Time Frame: 2022/8/10-2024/2/28 ]
    A brief multidimensional scale for assessing sexual function in women.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Menopause for one year Age above 45 with symptoms of GSM
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05483634


Contacts
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Contact: Hui-Hsuan Lau +886-25433535 huihsuan1220@gmail.com

Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Principal Investigator: Hui-Hsuan Lau Mackay Memorial Hospital
Publications:
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Responsible Party: Hui-Hsuan Lau, Doctor, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT05483634    
Other Study ID Numbers: 19MMHIS340e
First Posted: August 2, 2022    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs