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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 28, 2012
September 7, 2012
December 4, 2014
January 14, 2015
January 14, 2015
November 2012
August 2013   (Final data collection date for primary outcome measure)
  • 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).
Daily diary ratings of frequency and severity of hot flashes [ Time Frame: Change from baseline at Week 8 and post treatment -up. ]
Hot flash frequency and severity will be recorded daily in the am and pm. 7-day averages will be used at baseline, week 4 and week 8.
Complete list of historical versions of study NCT01680900 on ClinicalTrials.gov Archive Site
  • 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.
Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes [ Time Frame: Percent change from baseline at Week 8 ]
Frequency of hot flashes calculated from daily diaries
  • 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.
  • Menopause-related quality of life (MENQOL) [ Time Frame: Change from baseline at Week 8 ]
    The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory.
  • Adverse Symptoms Checklist [ 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.
  • Patient Satisfaction Ratings [ Time Frame: Week 8 ]
    Patient global rating of satisfaction with medication.
  • 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.
 
Vilazodone for Menopausal Hot Flashes
Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hot Flushes
  • Drug: 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.
    Other Name: viibryd
  • Drug: placebo capsules
    placebo capsules matched to drug capsules.
  • Experimental: experimental 1
    vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
    Intervention: Drug: vilazodone
  • Placebo Comparator: placebo capsules (sugar pill)
    Placebo capsules matched to the drug dose for 8 weeks
    Intervention: Drug: placebo capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ages 45-60 years
  • Amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy.
  • 4 or more moderate or severe hot flashes or night sweats per 24 hour period (28/week) as recorded on daily diaries in 3 screening weeks.
  • Hot flashes/night sweats rated as moderate to severe and/or bothersome (moderately to a lot) on 4 or more days/nights in each screen week.
  • In general good health.
  • Signed informed consent.

Exclusion Criteria:

  • Psychotropic medications currently or within the last 30 days.
  • Current use of hormonal medications such as hormone therapy or hormonal contraception or any treatment for hot flashes (Prescription, over-the-counter or herbal).
  • Drug or alcohol abuse in the past year.
  • Lifetime diagnosis of psychosis or bipolar disorder.
  • Suicide attempt in the past 3 years or any current suicidal ideation.
  • Current major depression.
  • Not using a medically approved, non-hormonal method of birth control if sexually active and not postmenopausal (12 or more months since last menstrual period or bi-lateral oophorectomy).
  • Pregnancy, intending pregnancy or breast feeding.
  • Any severe of unstable medical illness, e.g., breast or ovarian cancer, seizure disorders, etc.
  • Current participation in another intervention study.
  • Inability or unwillingness to complete study procedures.
Sexes Eligible for Study: Female
45 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01680900
816164
No
Not Provided
Not Provided
Ellen Freeman, University of Pennsylvania
University of Pennsylvania
Forest Laboratories
Principal Investigator: Ellen W Freeman, PhD University of Pennsylvania
University of Pennsylvania
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP