Vilazodone for Menopausal Hot Flashes

This study has been completed.
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 10, 2014
Last verified: January 2014
  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:


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.


Enrollment: 36
Study Start Date: November 2012
Study Completion Date: August 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Dept OB/GYN, Mudd Professorship Suite
Philadelphia, Pennsylvania, United States, 19104
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 10, 2014
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 October 22, 2014