NCT01680900

Vilazodone for Menopausal Hot Flashes

Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a proposal to conduct a small clinical trial for proof in principle that vilazodone reduces the frequency and severity of menopausal hot flashes. An additional exploratory aim is to identify improvement in menopause-related quality of life. Healthy, perimenopausal women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats per day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of vilazodone or matching placebo pills. Flexible dosing of vilazodone will start at 10 mg once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at week 3 if unimproved. The primary outcome assessments are the frequency and severity of hot flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean scores from the daily diaries). The secondary outcome is clinical improvement, defined as hot flash frequency \>=50% decrease from baseline. Treatment-emergent adverse events will be monitored and patient ratings of tolerability will be obtained.

Conditions

• Hot Flushes

Interventions

Type	Name	Description
DRUG	vilazodone	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.
DRUG	placebo capsules	placebo capsules matched to drug capsules.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-09-07
• Last updated: 2015-01-14
• Results posted: 2015-01-14

Locations

1 site across 1 country: United States