Vilazodone for Menopausal Hot Flashes

University of Pennsylvania

Status

Completed

Conditions

Hot Flushes

Treatments

Drug: vilazodone

Drug: placebo capsules

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01680900

816164

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Female

Ages

45 to 60 years old

Volunteers

No Healthy Volunteers

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.