drugset / Trial / NCT00323635
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2006-04
- Primary completion
- 2010-01
- Completion
- 2011-01
Publications
- Background Roehrs T, Merlotti L, Petrucelli N, Stepanski E, Roth T. Experimental sleep fragmentation. Sleep. 1994 Aug;17(5):438-43. doi: 10.1093/sleep/17.5.438.
- Background Shaver JL, Paulsen VM. Sleep, psychological distress, and somatic symptoms in perimenopausal women. Fam Pract Res J. 1993 Dec;13(4):373-84.
- Background Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.
- Background Brooks JO 3rd, Friedman L, Bliwise DL, Yesavage JA. Use of the wrist actigraph to study insomnia in older adults. Sleep. 1993 Feb;16(2):151-5. doi: 10.1093/sleep/16.2.151.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolterodine | Small molecule | 4 mg | Oral |