Vilazodone for Menopausal Hot Flashes

NCT01680900 | Completed Results

• 1 other identifier: 816164
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flushes

Keywords

menopause; hot flashes; vilazodone

Outcome Measures

Primary Outcomes (2)

• Daily Diary Ratings of Frequency of Hot Flashes

  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.

  Week 8.

• Daily Diary Ratings of Severity of Hot Flashes

  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).

  Week 8.

Secondary Outcomes (2)

• Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes

  Percent change from baseline at Week 8

• Menopause-related Quality of Life (MENQOL)

  Week 8

Other Outcomes (3)

• Number of Participants With Adverse Events

  Baseline and Week 12

• Percentage of Participants That Were Satisfied or Very Satisfied

  Week 8

• Sheehan Global Ratings of Symptom (Hot Flash)Interference

  Change from Baseline at Week 8

Study Arms (2)

experimental 1

EXPERIMENTAL

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

Drug: vilazodone

placebo capsules (sugar pill)

PLACEBO COMPARATOR

Placebo capsules matched to the drug dose for 8 weeks

Drug: placebo capsules

Interventions

vilazodone DRUG

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.

Also known as: viibryd

experimental 1

placebo capsules DRUG

placebo capsules matched to drug capsules.

placebo capsules (sugar pill)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women ages 45-60 years
• Amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Forest Laboratories: collaborator

Study Sites (1)

Dept OB/GYN, Mudd Professorship Suite

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles

Results Point of Contact

• Title: Dr. Ellen Freeman
• Organization: University of Pennsylvania

freemane@mail.med.upenn.edu

215-662-3329

Study Officials

• Ellen W Freeman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Profesor

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 14, 2015
• Results First Posted: January 14, 2015

Record last verified: 2014-12

Locations

US (1)