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Hormone Therapy
Toviaz and Premarin Vaginal Cream for Overactive Bladder
Phase 4
Waitlist Available
Led By Eric Hurtado, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal Women defined as at least 12 months since last menstrual period
OAB symptoms for 6 months or longer with complaints of frequency (8 or more voids in a 24 hour period), and either 6 or more urgency episodes in 24 hours, and either 3 or more urge urinary incontinence episodes per 24 hours.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
The use of vaginal estrogen cream in conjunction with Toviaz will be more effective than the use of Toviaz alone for the treatment of overactive bladder.
Eligible Conditions
- Overactive Bladder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary frequency as measured by a 3 day voiding diary
Secondary outcome measures
Overactive Bladder
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Toviaz and Premarin Vaginal CreamExperimental Treatment2 Interventions
Toviaz 4 mg PO q day and premarin cream 1 g per vagina 2 times a week.
Group II: Toviaz , Placebo Premarin Vaginal CreamPlacebo Group2 Interventions
Toviaz 4 mg PO q day and placebo cream 1 g per vagina 2 times a week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fesoterodine
FDA approved
Conjugated estrogens
FDA approved
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,364,985 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,358 Total Patients Enrolled
Alexandriah Alas, MDStudy DirectorCleveland Clinic Florida
1 Previous Clinical Trials
176 Total Patients Enrolled
Frequently Asked Questions
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