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Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome

NCT05221021 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-08-19

No results posted yet for this study

Summary

A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.

Conditions

  • Overactive Bladder Syndrome

Interventions

DRUG

Vaginal estrogen

0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill

DRUG

Mirabegron 50 MG [Myrbetriq]

50mg oral Mirabegron once daily

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Christopher W Heuer, DO · Urogynecology Fellow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2026-12-30
Completion
2027-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05221021 on ClinicalTrials.gov