Back to resultsVilazodone for Menopausal Hot Flashes
Primary Purpose
Hot Flushes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vilazodone
placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flushes focused on measuring menopause, hot flashes, vilazodone
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.
Sites / Locations
- Dept OB/GYN, Mudd Professorship Suite
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental 1
placebo capsules (sugar pill)
Arm Description
vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
Placebo capsules matched to the drug dose for 8 weeks
Outcomes
Primary Outcome Measures
Daily Diary Ratings of Frequency of Hot Flashes
Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.
Daily Diary Ratings of Severity of Hot Flashes
Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).
Secondary Outcome Measures
Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes
Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries
Menopause-related Quality of Life (MENQOL)
The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.
Full Information
NCT ID
NCT01680900
First Posted
August 28, 2012
Last Updated
January 13, 2015
Sponsor
University of Pennsylvania
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01680900
Brief Title
Vilazodone for Menopausal Hot Flashes
Official Title
Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flushes
Keywords
menopause, hot flashes, vilazodone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental 1
Arm Type
Experimental
Arm Description
vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
Arm Title
placebo capsules (sugar pill)
Arm Type
Placebo Comparator
Arm Description
Placebo capsules matched to the drug dose for 8 weeks
Intervention Type
Drug
Intervention Name(s)
vilazodone
Other Intervention Name(s)
viibryd
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo capsules
Intervention Description
placebo capsules matched to drug capsules.
Primary Outcome Measure Information:
Title
Daily Diary Ratings of Frequency of Hot Flashes
Description
Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.
Time Frame
Week 8.
Title
Daily Diary Ratings of Severity of Hot Flashes
Description
Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).
Time Frame
Week 8.
Secondary Outcome Measure Information:
Title
Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes
Description
Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries
Time Frame
Percent change from baseline at Week 8
Title
Menopause-related Quality of Life (MENQOL)
Description
The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.
Time Frame
Week 8
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events
Description
A 17 item checklist of general adverse and withdrawal symptoms. It will be used at baseline and Week 12. Adverse events will be obtained by subject report at Week 4 and Week 8.
Time Frame
Baseline and Week 12
Title
Percentage of Participants That Were Satisfied or Very Satisfied
Description
Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).
Time Frame
Week 8
Title
Sheehan Global Ratings of Symptom (Hot Flash)Interference
Description
Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.
Time Frame
Change from Baseline at Week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen W Freeman, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept OB/GYN, Mudd Professorship Suite
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Vilazodone for Menopausal Hot Flashes
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