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NCT00323635 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT00323635: Clinical Trial Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT00323635 is a Phase 4 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00323635, a Phase 4 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study 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.
Primary Outcome
Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.
Interventions
- DRUG tolterodine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
Why NCT00323635 stopped before completion
NCT00323635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which tolterodine is the first listed.
NCT00323635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00323635 about?
NCT00323635 is a clinical study titled "A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.". 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...
What is the current status of trial NCT00323635?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2006-04. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00323635?
The interventions under investigation include: tolterodine (DRUG).
Who is sponsoring clinical trial NCT00323635?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00323635's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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