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Hormone Therapy
Vaginal Estrogen for Urinary Tract Infections (TAPER Trial)
Phase 2
Recruiting
Led By Stephanie W Zuo, MD
Research Sponsored by Stephanie Wang Zuo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
TAPER Trial Summary
This trial aimed to compare the two methods of vaginal estrogen application.
Who is the study for?
This trial is for postmenopausal women who've had at least 2 UTIs in the last 6 months or 3 in a year, and are recommended vaginal estrogen to prevent more UTIs. They shouldn't be currently using any estrogen products, have significant vaginal narrowing, bladder stones, risk of estrogen-dependent cancer, or conditions preventing them from applying the cream themselves.Check my eligibility
What is being tested?
The study compares two ways of using estradiol cream to prevent recurrent urinary tract infections: periurethral (around the urethra) versus intravaginal application. It aims to determine if applying less cream around the urethra is as effective as the standard intravaginal method.See study design
What are the potential side effects?
While not explicitly listed here, typical side effects of topical estradiol may include local irritation or itching, increased chance of developing a rash or infection at the site of application.
TAPER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who are UTI-free at 6 months
Secondary outcome measures
Amount of estrogen cream used
Change from baseline in Vaginal and urinary E. coli levels at 6 months
Change from baseline in Vaginal and urinary Lactobacillus levels at 6 months
+6 moreTAPER Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Periurethral Estrogen ApplicationExperimental Treatment1 Intervention
Periurethral application of 0.5 gram estradiol cream at bedtime twice a week for 6 months
Group II: Intravaginal Estrogen ApplicationActive Control1 Intervention
Intravaginal application of 1 gram estradiol cream at bedtime twice a week for 6 months
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Who is running the clinical trial?
Stephanie Wang ZuoLead Sponsor
Stephanie W Zuo, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using vaginal or oral estrogen products.I am unable to give my own consent for medical procedures.I have severe vaginal narrowing that prevents the use of vaginal devices.I take antibiotics every day.I use a catheter for urination.I am currently receiving treatment for a cancer that grows with estrogen.I am postmenopausal, meeting the age or lab criteria if I had a hysterectomy.I use bladder treatments with antibiotics at least once a week.I have bladder stones, mesh erosion into my bladder, or a foreign object in my bladder.I have had 2 or more UTIs in 6 months or 3 or more in a year.I stopped using vaginal estrogen over 3 months ago.I cannot or will not use vaginal estrogen.My doctor has recommended vaginal estrogen to prevent UTIs.I have swelling in my kidney due to not being able to fully empty my bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Periurethral Estrogen Application
- Group 2: Intravaginal Estrogen Application
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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