Trial Outcomes & Findings for Vilazodone for Menopausal Hot Flashes (NCT NCT01680900)
NCT ID: NCT01680900
Last Updated: 2015-01-14
Results Overview
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.
COMPLETED
NA
36 participants
Week 8.
2015-01-14
Participant Flow
Participant milestones
| Measure |
Experimental 1
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 (Sugar Pill)
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vilazodone for Menopausal Hot Flashes
Baseline characteristics by cohort
| Measure |
Experimental 1
n=24 Participants
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 (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 3.7 • n=99 Participants
|
52.7 years
STANDARD_DEVIATION 4.2 • n=107 Participants
|
51.9 years
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
12 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8.Population: all participants randomized to treatment
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.
Outcome measures
| Measure |
Placebo Capsules (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Experimental 1
n=24 Participants
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.
|
|---|---|---|
|
Daily Diary Ratings of Frequency of Hot Flashes
|
4.71 number of hot flashes
Interval 3.61 to 5.8
|
3.65 number of hot flashes
Interval 2.57 to 4.73
|
PRIMARY outcome
Timeframe: Week 8.Population: all participants randomized to treatment
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).
Outcome measures
| Measure |
Placebo Capsules (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Experimental 1
n=24 Participants
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.
|
|---|---|---|
|
Daily Diary Ratings of Severity of Hot Flashes
|
1.39 units on a scale
Interval 1.02 to 1.76
|
1.17 units on a scale
Interval 1.05 to 1.8
|
SECONDARY outcome
Timeframe: Percent change from baseline at Week 8Population: all participants with at least one treatment response
Percent of patients with n \>=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries
Outcome measures
| Measure |
Placebo Capsules (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Experimental 1
n=24 Participants
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.
|
|---|---|---|
|
Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes
|
83 percentage of participants
|
65 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8The 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.
Outcome measures
| Measure |
Placebo Capsules (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Experimental 1
n=24 Participants
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.
|
|---|---|---|
|
Menopause-related Quality of Life (MENQOL)
|
2.08 units on a scale
Interval 1.63 to 2.53
|
1.89 units on a scale
Interval 1.55 to 2.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12A 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.
Outcome measures
| Measure |
Placebo Capsules (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Experimental 1
n=24 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
6 participants
|
17 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 8Population: all participants with at least one treatment response.
Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).
Outcome measures
| Measure |
Placebo Capsules (Sugar Pill)
n=12 Participants
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
Experimental 1
n=24 Participants
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.
|
|---|---|---|
|
Percentage of Participants That Were Satisfied or Very Satisfied
|
75 percentage of participants
|
65 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline at Week 8Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.
Outcome measures
Outcome data not reported
Adverse Events
Experimental 1
Placebo Capsules (Sugar Pill)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental 1
n=24 participants at risk
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 (Sugar Pill)
n=12 participants at risk
Placebo capsules matched to the drug dose for 8 weeks
placebo capsules: placebo capsules matched to drug capsules.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
37.5%
9/24
|
0.00%
0/12
|
|
Gastrointestinal disorders
nausea
|
29.2%
7/24
|
0.00%
0/12
|
|
Nervous system disorders
headache
|
16.7%
4/24
|
16.7%
2/12
|
|
Nervous system disorders
dry mouth
|
16.7%
4/24
|
25.0%
3/12
|
|
Gastrointestinal disorders
dehydration
|
4.2%
1/24
|
25.0%
3/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place