N/A N=36 Randomized Quadruple-blind Treatment

Vilazodone for Menopausal Hot Flashes

Hot Flushes

Bottom Line

View on ClinicalTrials.gov: NCT01680900 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Daily Diary Ratings of Frequency of Hot Flashes — 3.65; 4.71 number of hot flashes — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: vilazodone (Drug); placebo capsules (Drug)
Age: Adult · 45+ yrs
Sex: Female
Sponsor: University of Pennsylvania
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Daily Diary Ratings of Frequency of Hot Flashes	3.65; 4.71	0.05
PRIMARY Daily Diary Ratings of Severity of Hot Flashes	1.17; 1.39	0.05
SECONDARY Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes	65; 83	<0.05 sig
SECONDARY Menopause-related Quality of Life (MENQOL)	1.89; 2.08	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

Women ages 45-60 years
Amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy.
4 or more moderate or severe hot flashes or night sweats per 24 hour period (28/week) as recorded on daily diaries in 3 screening weeks.
Hot flashes/night sweats rated as moderate to severe and/or bothersome (moderately to a lot) on 4 or more days/nights in each screen week.
In general good health.
Signed informed consent.

Exclusion Criteria

Psychotropic medications currently or within the last 30 days.
Current use of hormonal medications such as hormone therapy or hormonal contraception or any treatment for hot flashes (Prescription, over-the-counter or herbal).
Drug or alcohol abuse in the past year.
Lifetime diagnosis of psychosis or bipolar disorder.
Suicide attempt in the past 3 years or any current suicidal ideation.
Current major depression.
Not using a medically approved, non-hormonal method of birth control if sexually active and not postmenopausal (12 or more months since last menstrual period or bi-lateral oophorectomy).
Pregnancy, intending pregnancy or breast feeding.
Any severe of unstable medical illness, e.g., breast or ovarian cancer, seizure disorders, etc.
Current participation in another intervention study.
Inability or unwillingness to complete study procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01680900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.