Vilazodone for Menopausal Hot Flashes

Completed 36 enrolled University of Pennsylvania Forest Laboratories · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2012-11
Primary completion: 2013-08
Completion: 2013-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Experimental 1 vs Placebo Capsules (Sugar Pill); p = 0.05; Mean Difference (Final Values) -1.06 (95% CI -2.60 to -0.48); Regression, Linear NCT01680900 ↗

registry analysis (superiority or other test); Experimental 1 vs Placebo Capsules (Sugar Pill); p = 0.05; Mean Difference (Final Values) -0.22 (95% CI -0.74 to -0.21); Regression, Linear NCT01680900 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vilazodone	Small molecule	20 mg	—
Subject	Vilazodone	Small molecule	40 mg	—

Indications

No indication recorded.