Status:
TERMINATED
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
45-65 years
Phase:
PHASE4
Brief Summary
This study is being done to compare frequency of urination during the night when women take tolterodine tablets vs. when they take placebo tablets. We will also measure whether between these two trea...
Detailed Description
From midlife onwards, about half of women complain of poor sleep quality. One possible reason might be an increased frequency of need to urinate during the night. Women feel more frequent urges to uri...
Eligibility Criteria
Inclusion
- Post-menopausal women, age 45 to 65 years old.
- No menses for at least 6 months before the study start.
- Have at least 14 episodes of nocturia per week.
- Have at least 4 hot flashes daily.
- Overall good health, as evidenced by a letter from the primary care provider.
- Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
- Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.
Exclusion
- Use of anti-cholinergic, hypnotic or sedating drugs
- Presence of urinary retention, gastric retention, chronic severe constipation,or narrow-angled glaucoma.
- A urinary tract infection within a month of study start.
- Undiagnosed abnormal vaginal bleeding.
- Benign or malignant liver disease.
- History or presence of chronic alcoholism or medication addiction within the past 5 yrs.
- An acute systemic infection within seven days before the study start.
- Concurrent participation in another clinical trial and/or receiving an experimental medication/device in the last 30 days before admission to the study.
- History of shift work within the past 6 months.
- \-
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00323635
Start Date
April 1 2006
End Date
January 1 2011
Last Update
March 29 2018
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120