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Vilazodone for Menopausal Hot Flashes

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ClinicalTrials.gov Identifier: NCT01680900
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ellen Freeman, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hot Flushes
Interventions Drug: vilazodone
Drug: placebo capsules
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Period Title: Overall Study
Started 24 12
Completed 20 11
Not Completed 4 1
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill) Total
Hide Arm/Group Description

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Total of all reporting groups
Overall Number of Baseline Participants 24 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 12 participants 36 participants
51.5  (3.7) 52.7  (4.2) 51.9  (3.9)
[1]
Measure Description: self-reported age in years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Female
24
 100.0%
12
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 12 participants 36 participants
24 12 36
1.Primary Outcome
Title Daily Diary Ratings of Frequency of Hot Flashes
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
all participants randomized to treatment
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description:

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Overall Number of Participants Analyzed 24 12
Mean (95% Confidence Interval)
Unit of Measure: number of hot flashes
3.65
(2.57 to 4.73)
4.71
(3.61 to 5.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental 1, Placebo Capsules (Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-2.60 to -0.48
Estimation Comments [Not Specified]
2.Primary Outcome
Title Daily Diary Ratings of Severity of Hot Flashes
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
all participants randomized to treatment
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description:

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Overall Number of Participants Analyzed 24 12
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.17
(1.05 to 1.80)
1.39
(1.02 to 1.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental 1, Placebo Capsules (Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.74 to -0.21
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
all participants with at least one treatment response
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description:

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: percentage of participants
65 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental 1, Placebo Capsules (Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Menopause-related Quality of Life (MENQOL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description:

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Overall Number of Participants Analyzed 24 12
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.89
(1.55 to 2.24)
2.08
(1.63 to 2.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental 1, Placebo Capsules (Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.75 to -0.08
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Number of Participants With Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description:

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: participants
17 6
6.Other Pre-specified Outcome
Title Percentage of Participants That Were Satisfied or Very Satisfied
Hide Description Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
all participants with at least one treatment response.
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description:

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

Overall Number of Participants Analyzed 24 12
Measure Type: Number
Unit of Measure: percentage of participants
65 75
7.Other Pre-specified Outcome
Title Sheehan Global Ratings of Symptom (Hot Flash)Interference
Hide 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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental 1 Placebo Capsules (Sugar Pill)
Hide Arm/Group Description

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

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.

Placebo capsules matched to the drug dose for 8 weeks

placebo capsules: placebo capsules matched to drug capsules.

All-Cause Mortality
Experimental 1 Placebo Capsules (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental 1 Placebo Capsules (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental 1 Placebo Capsules (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   17/24 (70.83%)   6/12 (50.00%) 
Gastrointestinal disorders     
diarrhea   9/24 (37.50%)  0/12 (0.00%) 
nausea   7/24 (29.17%)  0/12 (0.00%) 
dehydration   1/24 (4.17%)  3/12 (25.00%) 
Nervous system disorders     
headache   4/24 (16.67%)  2/12 (16.67%) 
dry mouth   4/24 (16.67%)  3/12 (25.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ellen Freeman
Organization: University of Pennsylvania
Phone: 215-662-3329
EMail: freemane@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: Ellen Freeman, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01680900     History of Changes
Other Study ID Numbers: 816164
First Submitted: August 28, 2012
First Posted: September 7, 2012
Results First Submitted: December 4, 2014
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015