Vilazodone for Menopausal Hot Flashes

Hot Flushes Clinical Trial

Official title:

Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680900
• Other study ID #: 816164
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: January 13, 2015
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Hot Flushes

Intervention

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.
• placebo capsules
placebo capsules matched to drug capsules.

Locations

Country	Name	City	State
United States	Dept OB/GYN, Mudd Professorship Suite	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events	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.	Baseline and Week 12	Yes
Other	Percentage of Participants That Were Satisfied or Very Satisfied	Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).	Week 8	Yes
Other	Sheehan Global Ratings of Symptom (Hot Flash)Interference	Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.	Change from Baseline at Week 8	No
Primary	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.	No
Primary	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.	No
Secondary	Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes	Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries	Percent change from baseline at Week 8	No
Secondary	Menopause-related Quality of Life (MENQOL)	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.	Week 8	No