Trial Outcomes & Findings for Vilazodone for Menopausal Hot Flashes (NCT NCT01680900)

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Week 8.

Results posted on

2015-01-14

Participant Flow

Participant milestones

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

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=93 Participants	52.7 years STANDARD_DEVIATION 4.2 • n=4 Participants	51.9 years STANDARD_DEVIATION 3.9 • n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	12 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	24 participants n=93 Participants	12 participants n=4 Participants	36 participants n=27 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

Outcome measures
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.
Daily Diary Ratings of Frequency of Hot Flashes	3.65 number of hot flashes Interval 2.57 to 4.73	4.71 number of hot flashes Interval 3.61 to 5.8

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

Outcome measures
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.
Daily Diary Ratings of Severity of Hot Flashes	1.17 units on a scale Interval 1.05 to 1.8	1.39 units on a scale Interval 1.02 to 1.76

SECONDARY outcome

Timeframe: Percent change from baseline at Week 8

Population: 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

Outcome measures
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.
Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes	65 percentage of participants	83 percentage of participants

SECONDARY outcome

Timeframe: Week 8

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.

Outcome measures

Outcome measures
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.
Menopause-related Quality of Life (MENQOL)	1.89 units on a scale Interval 1.55 to 2.24	2.08 units on a scale Interval 1.63 to 2.53

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
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.
Number of Participants With Adverse Events	17 participants	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Population: 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

Outcome measures
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.
Percentage of Participants That Were Satisfied or Very Satisfied	65 percentage of participants	75 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline at Week 8

Global 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

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo Capsules (Sugar Pill)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Ellen Freeman

University of Pennsylvania

Phone: 215-662-3329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place