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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. Identifier: NCT01680900
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Forest Laboratories
Information provided by (Responsible Party):
Ellen Freeman, University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hot Flushes Drug: vilazodone Drug: placebo capsules Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: experimental 1
vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
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

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.

Primary Outcome Measures :
  1. 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.

  2. 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).

Secondary Outcome Measures :
  1. 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

  2. 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.

Other Outcome Measures:
  1. 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.

  2. 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).

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01680900

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United States, Pennsylvania
Dept OB/GYN, Mudd Professorship Suite
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Forest Laboratories
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Principal Investigator: Ellen W Freeman, PhD University of Pennsylvania

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Responsible Party: Ellen Freeman, Research Profesor, University of Pennsylvania Identifier: NCT01680900     History of Changes
Other Study ID Numbers: 816164
First Posted: September 7, 2012    Key Record Dates
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015
Last Verified: December 2014
Keywords provided by Ellen Freeman, University of Pennsylvania:
hot flashes
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists