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NCT06353269 · ClinicalTrials.gov registry record · Phase 4
Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections
A Phase 4 study of Recurrent Urinary Tract Infection and Hypoestrogenism, sponsored by University of California, Irvine.
- Active
- Registry status
- Phase 4
- Development phase
- 111
- Enrollment target
- 1
- Study location
NCT06353269 is a Phase 4 study of Recurrent Urinary Tract Infection and Hypoestrogenism that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 111 participants, above the 87-participant average among 4 other Recurrent Urinary Tract Infection trials with a reported enrollment target (28% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06353269, a Phase 4 study of Recurrent Urinary Tract Infection and Hypoestrogenism, is active but no longer recruiting, sponsored by University of California, Irvine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 111 participants
- Enrollment target
- 1
- Study location
Study Summary
* The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed. * Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound. * A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina. Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring. * The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires. * There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed. If a participant is part of the microbiome cohort, they will also be asked to do the following: * a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear. * Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves th
Conditions Studied
Interventions
- DRUG Estrace 0.01% Vaginal Cream
- DRUG Estring Vaginal Product
- DRUG Vagifem
Study Locations (1)
California
- University of California Irvine Medical Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2024-06-14 |
| Est. Completion | 2027-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06353269
The ClinicalTrials.gov registry entry for NCT06353269 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 4 other Recurrent Urinary Tract Infection trials with a reported enrollment target (28% higher). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Recurrent Urinary Tract Infection appearing as the primary indexed condition, and to 3 interventions - of which Estrace 0.01% Vaginal Cream is the first listed.
NCT06353269 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06353269 about?
NCT06353269 is a clinical study titled "Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections". * The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as p...
What is the current status of trial NCT06353269?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 111 participants. The study started on 2024-06-14. Estimated completion is 2027-09.
What conditions does trial NCT06353269 study?
This clinical trial studies the following conditions: Recurrent Urinary Tract Infection, Hypoestrogenism.
What interventions are being tested in trial NCT06353269?
The interventions under investigation include: Estrace 0.01% Vaginal Cream (DRUG), Estring Vaginal Product (DRUG), Vagifem (DRUG).
Who is sponsoring clinical trial NCT06353269?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06353269 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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