Vilazodone for Menopausal Hot Flashes
Completed · Not applicable · Has a placebo group
Conditions studied: Hot Flushes
In brief
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.
Key facts
- Study ID
- NCT01680900
- Run by
- University of Pennsylvania
- People needed
- 36
- Starts
- 2012-11-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2015-01-14
Who can join
Age: 45 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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.
Where it is running
- Dept OB/GYN, Mudd Professorship Suite — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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