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Vilazodone for Menopausal Hot Flashes

This study is currently recruiting participants.
Verified January 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ellen Freeman, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01680900
First received: August 28, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Hot Flushes
 Drug: vilazodone
Drug: placebo capsules

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Daily diary ratings of frequency and severity of hot flashes [ Time Frame: Change from baseline at Week 8 and post treatment -up. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ]
    Frequency of hot flashes calculated from daily diaries


Other Outcome Measures:
  • Menopause-related quality of life (MENQOL) [ Time Frame: Change from baseline at 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.

  • Adverse Symptoms Checklist [ 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.

  • Patient Satisfaction Ratings [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    Patient global rating of satisfaction with medication.

  • 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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680900

Contacts
Contact: Ellen W Freeman, PhD 215-662-3329 freemane@mail.med.upenn.edu

Locations
United States, Pennsylvania
Dept OB/GYN, Mudd Professorship Suite Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ellen W Freeman, PhD     215-662-3329     freemane@mail.med.upenn.edu    
Contact: Cheryl Irving, BA     215-662-3329     cirving@mail.med.upenn.edu    
Principal Investigator: Ellen W Freeman, PhD            
Sponsors and Collaborators
University of Pennsylvania
Forest Laboratories
Investigators
Principal Investigator: Ellen W Freeman, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Ellen Freeman, Research Profesor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01680900     History of Changes
Other Study ID Numbers: 816164
Study First Received: August 28, 2012
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
menopause
hot flashes
vilazodone

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013