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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240514001

Enrollment

Registered

2024-05-14

Start date

2023-08-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary syndromes of menopause Vaginal dryness Hormone replacement therapy GSM Menopause Vaginal dryness Microbiome genitourinary syndrome of menopause

Interventions

vaginal estradiol 10 micrograms ,Vaginal placebo tablet

Experimental Drug,Placebo Comparator No treatment

Estradiol ,Placebo

Eligibility

Sex/Gender

Female

Age

45 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
characteristics of vaginal microbiome At baseline and 12 week after intervention 16s rRNA next generation sequencing	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactAruchaporn Rongthong

The Thai Redcross Society

Aruchaporn.rt@gmail.com0896385587

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026