What this trial studies
The goal of this Pre-Post Quasi-experimental study is to investigates the effect of vaginal estrogen therapy on changes in the urinary microbiome and its association with improvement in overactive bladder (OAB) symptoms in menopausal women Primary Objective: To evaluate the effects of vaginal estrogen on the level of Lactobacillus in the urine of postmenopausal women with OAB. Secondary Objectives 1. To evaluate the effects of vaginal estrogen on urine microbiome in postmenopausal women with OAB. 2.
Conditions in scope
- Overactive Bladder (OAB)
- Menopause
- Microbiome
Interventions
- 17β-estradiol 10 mcg (Drug) — 17β-estradiol 10 mcg will be given to all participants. The participants will be asked to use 1 tab daily for 2 weeks vaginally before bed, then 1 tab twice a week vaginally before bed until 12 weeks
Who can join
Women only · Adults (Child, Adult, Older Adult)
Inclusion criteria
- Natural or surgical menopause at least 1 year
- Present with overactive bladder symptoms by using validated Thai version of OVERACTIVE BLADDER SYMPTOM SCORE (score in No.3 ≥ 2 and overall score ≥ 3)
- Absence of urinary infection
- Post-void residual urine less than 100ml
Exclusion criteria
- Currently or prior use of systemic hormone replacement therapy or vaginal estrogen within the past 3 months
- Contraindication or allergy to estrogen therapy
- Use of antibiotics, prebiotics and probiotics within the past 2 weeks
- Currently on antimuscarinic or β3 agonists medication or within the past 3 months
- Pelvic organ prolapse greater than stage II
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Bangkok | Faculty of Medicine Ramathibodi Hospital, Mahidol University | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: PHASE4
- Start date: 2025-06-27
- Primary completion: 2025-11-10
- Last update posted: 2026-02-09
- First posted: 2025-01-17
Sponsor & contact
Lead sponsor: Mahidol University (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change in Lactobacillus abundance (From enrollment to the end of treatment at 12 weeks)
Change in Lactobacillus abundance (measure by urine microbiome study) after vaginal estrogen therapy
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06780163 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.