Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 195
- 主要终点
- Difference in average hot flash score from baseline until week 7 of treatment
研究概览
简要总结
RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast cancer. It is not yet known which dose of citalopram is more effective in treating hot flashes in postmenopausal women.
PURPOSE: This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash scores in postmenopausal women with a history of breast cancer or in postmenopausal women who do not wish to take estrogen replacement therapy for fear of increased risk of breast cancer.
Secondary
- Compare the side effect profile of these regimens in these patients.
- Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes.
- Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
high-dose citalopram hydrobromide
Patients receive 1 tablet of oral citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once daily in weeks 4-7.
All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
干预措施: citalopram hydrobromide (Drug)
placebo
Patients receive 1-3 placebo tablets once daily in weeks 2-7.
All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
干预措施: placebo (Other)
low-dose citalopram hydrobromide
Patients receive 1 tablet of oral citalopram once daily in weeks 2-7.
All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
干预措施: citalopram hydrobromide (Drug)
medium-dose citalopram hydrobromide
Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7.
All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
干预措施: citalopram hydrobromide (Drug)
结局指标
主要结局
Difference in average hot flash score from baseline until week 7 of treatment
时间窗: Up to 7 weeks
次要结局
- Toxicity(Up to 7 weeks)
- Mood- and hot flash-related daily interference with activities(Up to 7 weeks)