Clinical trial NCT01680900: Vilazodone for Menopausal Hot Flashes
Official title: Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flushes
Keywords: menopause
hot flashes
vilazodone
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2012-09-07
Enrollment: 36
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Daily Diary Ratings of Frequency of Hot Flashes
timeFrame: Week 8.
measure: Daily Diary Ratings of Severity of Hot Flashes
timeFrame: Week 8.
Secondary outcomes:
measure: Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes
timeFrame: Percent change from baseline at Week 8
measure: Menopause-related Quality of Life (MENQOL)
timeFrame: Week 8
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Baseline and Week 12
measure: Percentage of Participants That Were Satisfied or Very Satisfied
timeFrame: Week 8
measure: Sheehan Global Ratings of Symptom (Hot Flash)Interference
timeFrame: Change from Baseline at Week 8
Locations:
city: Philadelphia
country: United States
facility: Dept OB/GYN, Mudd Professorship Suite
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ellen W Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: