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NCT Number: NCT05483634

Compare 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.

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Key information

Conditions

Menopause Estrogen Replacement Therapy Platelet-Rich Plasma Vaginal Atrophy

Age range

45 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Lau

CONTACT

[email protected]

+886-25433535

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 2, 2022
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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