Vilazodone for Menopausal Hot Flashes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|