Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (DRIVE)
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ClinicalTrials.gov Identifier: NCT00465894 |
Recruitment Status :
Completed
First Posted : April 25, 2007
Results First Posted : October 23, 2012
Last Update Posted : November 1, 2018
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Sponsor:
University of Alabama at Birmingham
Collaborator:
Pfizer
Information provided by (Responsible Party):
David Rich Ellington, University of Alabama at Birmingham
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Overactive Bladder |
Interventions |
Drug: Extended Release Tolterodine LA Drug: Intra Vaginal Estradiol Cream |
Enrollment | 58 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Group 1: Extended Release Tolterodine | Group 2: Intra Vaginal Estradiol Cream |
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4 mg Tolterodine po daily for 12 weeks At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks. |
0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks |
Period Title: Treatment For 12 Weeks | ||
Started | 30 | 28 |
Completed | 25 | 25 |
Not Completed | 5 | 3 |
Reason Not Completed | ||
Lost to Follow-up | 4 | 1 |
Family Issues | 1 | 1 |
Withdrawal by Subject | 0 | 1 |
Period Title: Treatment From 12 Weeks To 24 Weeks | ||
Started | 14 [1] | 14 [1] |
Completed | 14 | 14 |
Not Completed | 0 | 0 |
[1]
We included data only from participants that had complete data sets.
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Period Title: Treatment From 24 Weeks to 52 Weeks | ||
Started | 11 [1] | 14 |
Completed | 11 | 14 |
Not Completed | 0 | 0 |
[1]
We included data only from participants that had complete data sets.
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Baseline Characteristics
Arm/Group Title | Group 1: Extended Release Tolterodine | Group 2: Intra Vaginal Estradiol Cream | Total | |
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4 mg Tolterodine po daily for 12 weeks | 0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 30 | 28 | 58 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 30 participants | 28 participants | 58 participants | |
63 (6) | 60 (2) | 61.5 (4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 30 participants | 28 participants | 58 participants | |
Female |
30 100.0%
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28 100.0%
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58 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Holly E. Richter |
Organization: | University of Alabama at Birmingham |
Phone: | 205-934-1704 |
EMail: | hrichter@uabmc.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | David Rich Ellington, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00465894 |
Other Study ID Numbers: |
F061208008 IIR - DRIVE |
First Submitted: | April 23, 2007 |
First Posted: | April 25, 2007 |
Results First Submitted: | June 1, 2012 |
Results First Posted: | October 23, 2012 |
Last Update Posted: | November 1, 2018 |