Vilazodone for Menopausal Hot Flashes
|ClinicalTrials.gov Identifier: NCT01680900|
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hot Flushes||Drug: vilazodone Drug: placebo capsules||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
- Daily Diary Ratings of Frequency of Hot Flashes [ Time Frame: Week 8. ]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. ]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 ]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 ]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 ]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 ]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 ]Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680900
|United States, Pennsylvania|
|Dept OB/GYN, Mudd Professorship Suite|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ellen W Freeman, PhD||University of Pennsylvania|