A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT00323635

Run by

Brigham and Women's Hospital

People needed

19

Starts

2006-04-01

Expected to finish

2011-01-01

Last updated by the study team

2018-03-29

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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