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Hormone Therapy
Premarin Versus Toviaz for Treatment of 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Urinary frequency as measured by a 3 day voiding diary
Secondary study objectives
Overactive Bladder
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
1,057 Previous Clinical Trials
1,371,382 Total Patients Enrolled
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,092 Total Patients Enrolled
Eric Hurtado, MDPrincipal InvestigatorCleveland Clinic Florida
2 Previous Clinical Trials
116 Total Patients Enrolled
Alexandriah Alas, MDStudy DirectorCleveland Clinic Florida
1 Previous Clinical Trials
176 Total Patients Enrolled