Status:
COMPLETED
A Phase IV Study of Cipro XR in Uncomplicated UTI
Lead Sponsor:
Bayer
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a bro...
Eligibility Criteria
Inclusion
- Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
- Positive leukocyte esterase (\>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
- Willing to give written consent.
Exclusion
- Pregnant or nursing
- Complicated UTI
- Allergy to Cipro XR
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
7614 Patients enrolled
Trial Details
Trial ID
NCT00663806
Start Date
February 1 2003
End Date
July 1 2003
Last Update
December 2 2014
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