Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

What this trial studies

Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women. However, prior studies have shown the compliance rate for topical estrogen cream is low. The vaginal estradiol tablet has been shown to be preferred by patients being treated for genitourinary syndrome of menopause and has improved compliance. There are no studies looking at the preference of post-menopausal women with rUTI for vaginal estradiol tablet as an alternative to vaginal estradiol cream.

Conditions in scope

• Recurrent Urinary Tract Infection

Interventions

• Estradiol vaginal cream (Drug) — Participants will use vaginal estradiol cream for 3 months
• Estradiol Vaginal Tablet (Drug) — Participants will use vaginal estradiol tablet for 3 months

Who can join

Women only · Ages 20 Years to 80 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2024-01-12
• Primary completion: 2027-01
• Last update posted: 2025-12-02
• First posted: 2023-02-10

Sponsor & contact

Lead sponsor: Wake Forest University Health Sciences (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

• Patient preference rate for vaginal estradiol cream versus tablet (month 6)
  Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?"

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.