Suspended

Vaginal Estradiol Cream and Tablet for Recurrent UTI Prevention in Post-menopausal Women

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Study Aim

This study aims to evaluate the preference between vaginal estradiol cream and tablet for preventing recurrent urinary tract infections in post-menopausal women.

What is being tested

Estradiol vaginal cream

+ Estradiol Vaginal Tablet

Drug
Who is being recruted

Urogenital Diseases+4

+ Female Urogenital Diseases and Pregnancy Complications

+ Infections

From 20 to 80 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 12, 2024

Actual date on which the first participant was enrolled.

This study focuses on preventing recurring urinary tract infections (rUTIs) in post-menopausal women. It aims to find out whether women prefer using vaginal estradiol cream or vaginal estradiol tablets. This is important because recurring UTIs can be uncomfortable and challenging to manage, especially for women who have gone through menopause. Understanding preferences for treatment options can help doctors provide better, more personalized care to reduce the occurrence of these infections. Participants in the study will try both forms of treatment over six months. One group will use the cream for three months and then switch to the tablets, while the other group will do the opposite. Throughout the study, participants might also use other supplements like cranberry or D-mannose, depending on their doctor's advice. They will receive monthly phone calls to check for any side effects, safety issues, or UTI symptoms. At the end of six months, or if they choose to leave the study early, participants will be asked which form of treatment they prefer.

Official TitleAddressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial
NCT05723601
Principal SponsorWake Forest University Health Sciences
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsInfectionsUrinary Tract InfectionsUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: * Women age 20-80 who are post-menopausal or have undergone surgical menopause. Post-menopausal defined as amenorrhea for ≥ 1 year, or surgical menopause through bilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with prior hysterectomy * New or previous diagnosis of recurrent Urinary Tract Infections (rUTI) (3 or more UTIs in the past year or 2 or more UTIs in the last 6 months) Must have at least one culture documented UTI, the remaining can be documented by urinalysis showing nitrites and leukocyte esterase. * Not currently taking daily prophylactic antibiotics * Willing to use vaginal estrogen for prevention of recurrent UTIs Exclusion Criteria: * Interstitial cystitis or bladder pain syndrome, nephrolithiasis, genitourinary abnormalities, fistula, history of renal transplant or anatomic abnormality of the kidney * Fecal incontinence, intermittent catheterization or indwelling catheter, poorly controlled DM, urothelial cancer, estrogen-sensitive cancer including active breast cancer * Recent urologic surgery within 3 months * Inability to retain vaginal tablet (ex due to advanced prolapse, history of colpocleisis) * Other medical reasons that are deemed incompatible with vaginal estrogen treatment * Use of vaginal estrogen in the past 1 month- patients can be recruited after a 1 month wash-out period * Inability to follow up at clinic study site to give sample, for example due to transportation issues * Organ transplant patients * Patients on systemic hormone replacement therapy (HRT)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
participants will start with 3 months of cream and then switch to tablets

Group II

Active Comparator
participants will start with 3 months of tablets and switch to cream

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Wake Forest University Health Sciences

Winston-Salem, United StatesOpen Wake Forest University Health Sciences in Google Maps
SuspendedOne Study Center