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Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
NCT06353269Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2024
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- University of California, Irvine
- Conditions
- urinary tract infection (UTI)hypoestrogenism
01
Overview
Phase 4, randomised, open-label trial of estradiol vaginal cream in urinary tract infection (UTI) and hypoestrogenism (3 arms), sponsored by University of California, Irvine. Primary endpoint: Adherence to vaginal estrogen treatment at 6 months. Started Jun 2024; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Estrogen cream
Estrace 0.01% Vaginal Cream applied 0.5gm twice per week.
Estrogen tablet
Vagifem tablet (10 mcg) placed into the vagina twice per week.
Estrogen drug-eluting ring
Estring Vaginal Product placed by a provider and exchanged every 12 weeks.
03
Who it enrols
Female patients at least 18 years old with hypoestrogenism and recurrent urinary tract infections. Excludes patients with known etiology of infections, contraindications to vaginal estrogen, suspected mesh complications, short vaginal length, or poorly controlled diabetes.
04
Endpoints
Primary
Adherence to vaginal estrogen treatment
Secondary
Urinary Tract Infection rates
Urinary Distress Inventory Short Form
UTI Symptoms Assessment Questionnaire
Treatment Satisfaction with Medications Questionnaire
Patient Global Impression of Improvement Questionnaire
Medication Adherence Report Scale
Vaginal epithelial thickness via optical coherence tomography
Blood vessel density via optical coherence tomography
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