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NCT00702949 · ClinicalTrials.gov registry record · Phase 3
Pregabalin in Treating Women With Hot Flashes
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 207
- Enrollment target
NCT00702949: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00702949 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 207 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00702949, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 207 participants
- Enrollment target
Study Summary
RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes. PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.
Primary Outcome
Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations fo
Interventions
- OTHER placebo
- DRUG pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2008-06 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT00702949 record still lists
NCT00702949 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00702949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00702949 about?
NCT00702949 is a clinical study titled "Pregabalin in Treating Women With Hot Flashes". RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes. P...
What is the current status of trial NCT00702949?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 207 participants. The study started on 2008-06. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00702949?
The interventions under investigation include: placebo (OTHER), pregabalin (DRUG).
Who is sponsoring clinical trial NCT00702949?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00702949's enrollment target sits among peer trials
207 1346th of 2000 higher than 654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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