Effect of vaginal estradiol 10 micrograms on vaginal microbiome in women with genitourinary syndrome of menopause : A Randomized Controlled Trial

Phase 3

Completed

• Conditions: Genitourinary syndromes of menopause Vaginal drynessHormone replacement therapy; GSM; genitourinary syndrome of menopause; Menopause; Vaginal dryness; Microbiome

• Registration Number: TCTR20240514001
• Lead Sponsor: Ratchadapiseksompotch Fund, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-01-26
• Study Start: 2024-05-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Two or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy)
2. Moderate to severe genitourinary symptoms ( at least one symptom of burning, dryness, itching, irritation, soreness and/or bleeding, dyspareunia)
3. Follicle stimulating hormone (FSH) concentrations more than 40 IU/L
4. Serum estradiol concentrations 20 pg/mL or less

Exclusion Criteria

1. Previous hormone therapy in the past 3 months
2. Current use of a vaginal pessary, urinary tract infection
3. Antibiotic exposure or vaginal medications in the past 30 days
Any contraindications to estrogen
4. Systemic diseases or chronic conditions (diabetes mellitus, immunological disease), use of immuno suppressive drugs, exogenous corticosteroids, chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
characteristics of vaginal microbiome At baseline and 12 week after intervention 16s rRNA next generation sequencing

Secondary Outcome Measures

Name	Time	Method
The most bothersome symptom At baseline and 12 weeks after intervention The most bothersome symptom score using a questionnaire interview,Vaginal atrophy score (VAS) At baseline and 12 weeks after intervention Vaginal atrophy score By Vaginal examination ,Vaginal Maturation Value (VMV) At baseline and 12 weeks after intervention Vaginal Maturation Value by Cytologic examination,Vaginal health index (VHI) At baseline and 12 weeks after intervention Vaginal health index from Direct Vaginal examination ,Vaginal pH At baseline and 12 weeks after intervention Vaginal pH using pH indicator