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Which vaginal estrogen works best for recurrent UTIs? new study aims to find out

NCT ID NCT06353269

Disease control Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well women with low estrogen (like after menopause) stick to using vaginal estrogen treatments to prevent repeat urinary tract infections. About 111 women will be randomly assigned to use a cream, tablet, or ring. Researchers will track adherence over 6 months and also examine changes in vaginal tissue and natural bacteria.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vaginal estrogen (estradiol ring, tablet, or cream)
What this could lead to
If successful, this could show which vaginal estrogen form women are most likely to use consistently, potentially reducing recurrent UTIs.
What could go wrong
This is a small, single-site study focused on adherence, not on proving that one treatment works better than another. Results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 111 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * female, at least 18 years old with diagnosis of hypoestrogenism (defined by post-menopausal status of 12 months or more of amenorrhea, history of bilateral salpingo-oophorectomy) AND recurrent UTI as defined by greater than or equal to 3 in 1 year or 2 in 6 months by positive urine culture or clinically suspected UTI) Exclusion Criteria: * Have a known etiology of infections (urologic stones, fistulas, fecal incontinence, catheterization, or poorly controlled diabetes - Hgb A1C cutoff of 8) * Contraindication to vaginal estrogen (actively treated estrogen-sensitive tumor, allergies to medication formulation, inability to apply or place vaginal estrogen of any modality) * Suspected mesh complications or voiding problems from pelvic reconstructive surgery * Short vaginal length (less than 7cm) or poor dexterity or mobility that may prevent use of estrogen ring * Do not speak English * For the nested cohort only - patients currently using vaginal estrogen greater than 2x per month Deferral criteria: * Undiagnosed hematuria or vaginal bleeding; however enrollment may proceed after negative workup for malignancy * Remote history of estrogen-sensitive tumor: enrollment allowed after approval by oncologist or primary care physician

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Conditions

The condition(s) this trial relates to.

urinary tract infection urinary tract infections, recurrent, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoestrogenism Recurrent urinary tract infection

Contacts and locations

Locations

  • University of California Irvine Medical Center

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.