Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Daily Diary Ratings of Frequency of Hot Flashes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
experimental 1
vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks
干预措施: vilazodone (Drug)
placebo capsules (sugar pill)
Placebo capsules matched to the drug dose for 8 weeks
干预措施: placebo capsules (Drug)
结局指标
主要结局
Daily Diary Ratings of Frequency of Hot Flashes
时间窗: Week 8.
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.
Daily Diary Ratings of Severity of Hot Flashes
时间窗: Week 8.
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).
次要结局
- Menopause-related Quality of Life (MENQOL)(Week 8)
- Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes(Percent change from baseline at Week 8)
研究者
Ellen Freeman
Research Profesor
University of Pennsylvania