A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
NCT00323635
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1. Post-menopausal women, age 45 to 65 years old.
2. No menses for at least 6 months before the study start.
3. Have at least 14 episodes of nocturia per week.
4. Have at least 4 hot flashes daily.
5. Overall good health, as evidenced by a letter from the primary care provider.
6. Agree not to use exogenous hormones including soy isoflavones or soybean-based shakes, or nutritional supplements that potentially reduce hot flashes.
7. Have discontinued all hormone treatments, systemic, topical, or vaginal, at least 60 days before admission and throughout participation in the study.
1. Use of anti-cholinergic, hypnotic or sedating drugs
2. Presence of urinary retention, gastric retention, chronic severe constipation,or
narrow-angled glaucoma.
3. A urinary tract infection within a month of study start.
4. Undiagnosed abnormal vaginal bleeding.
5. Benign or malignant liver disease.
6. History or presence of chronic alcoholism or medication addiction within the past 5
yrs.
7. An acute systemic infection within seven days before the study start.
8. Concurrent participation in another clinical trial and/or receiving an experimental
medication/device in the last 30 days before admission to the study.
9. History of shift work within the past 6 months.
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Descriptive Information | ||||
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Brief Title ICMJE | A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause. | |||
Official Title ICMJE | A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women. | |||
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 treatment conditions there are any differences in women's sleep, mood and performance on cognitive tests. | |||
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 urinate when structures that support the bladder become more lax. Tolterodine is a drug that can raise the threshold for volume of urine that accumulates in the bladder before the urge to urinate arises. Many factors determine how people say they sleep, such as their sleep as recorded by sleep-measuring instruments, how closely they notice their night's sleep, whether they are generally prone to make positive or negative judgments or to have a lot or a few body symptoms. In this study, women between ages 45 to 65 who are past the menopause and who are frequently bothered by the need to urinate during the night will take either tolterodine or placebo tablets for 8 weeks. During the last week they will record the hours they slept and the quality of their sleep each morning. They will wear a device on their wrist through the week that continuously records whether they are asleep or awake. During three nights of the week they will record the volume of urine whenever they urinate. At the end of the week they will complete questionnaires about their mood and take some computerized tests that measure their alertness. Thereafter they will repeat these procedures, taking the kind of tablets they did not take during the first 8-week treatment period. We will compare the frequency of urination, sleep, mood as adjusted for the tendency to make positive or negative judgments and daytime attention level to find if any of these differ between the two treatment periods, and to explain differences between any differences that may be found. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Urinary Incontinence | |||
Intervention ICMJE | Drug: tolterodine
tablet, 4 mg, daily, 1 month Other Name: Detrol | |||
Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 19 | |||
Original Enrollment ICMJE | 49 | |||
Actual Study Completion Date ICMJE | January 2011 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00323635 | |||
Other Study ID Numbers ICMJE | 2005-P-000960 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Quentin Rodney Regestein, MD, Brigham and Women's Hospital | |||
Study Sponsor ICMJE | Brigham and Women's Hospital | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Brigham and Women's Hospital | |||
Verification Date | March 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |