At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 207 enrolled
Drug / intervention
pregabalin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes
In Brief
A Phase 3 clinical trial evaluating pregabalin and placebo for Breast Cancer and Hot Flashes. Completed, enrolled 207 participants across 209 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Hot Flashes
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionFeb 2010
Study CompletionMar 2015
TodayJul 2026
First PostedJun 20, 2008
Enrollment StartJun 1, 2008
Primary CompletionFeb 1, 2010
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.0 years ago
Interventions
pregabalindrug
Given orally
placeboother
Given orally