Vilazodone for Menopausal Hot Flashes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study|
- Daily Diary Ratings of Frequency of Hot Flashes [ Time Frame: Week 8. ] [ Designated as safety issue: No ]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 [ Time Frame: Week 8. ] [ Designated as safety issue: No ]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).
- Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes [ Time Frame: Percent change from baseline at Week 8 ] [ Designated as safety issue: No ]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) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]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.
- Number of Participants With Adverse Events [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]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.
- Percentage of Participants That Were Satisfied or Very Satisfied [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).
- Sheehan Global Ratings of Symptom (Hot Flash)Interference [ Time Frame: Change from Baseline at Week 8 ] [ Designated as safety issue: No ]Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.
|Study Start Date:||November 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: experimental 1
vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
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.
Other Name: viibryd
Placebo Comparator: placebo capsules (sugar pill)
Placebo capsules matched to the drug dose for 8 weeks
Drug: placebo capsules
placebo capsules matched to drug capsules.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680900
|United States, Pennsylvania|
|Dept OB/GYN, Mudd Professorship Suite|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ellen W Freeman, PhD||University of Pennsylvania|