At a glance
ClinicalIndex Comparison RecordN/ACompleted· 36 enrolled
Drug / intervention
vilazodone +1 moredrug
Likely dose
vilazodone 10 mgfrom 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.
Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study
In Brief
A clinical study evaluating vilazodone and placebo capsules for Hot Flushes. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This is a pilot study to determine proof in principle that vilazodone, a selective serotonin reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related quality of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flushes
CountriesUnited States
CollaboratorsForest Laboratories
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartNov 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedSep 7, 2012
Enrollment StartNov 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.8 years ago
Interventions
vilazodonedrug
capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved.
placebo capsulesdrug
placebo capsules matched to drug capsules.