Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number and severity records of hot flushes
研究概览
简要总结
- Introduction: Estrogen hormonal therapy associated or not with progestagen is the standard therapy for the treatment of hot flushes. However some women are not candidates for hormone replacement therapy for medical reasons or for choice.
- Main goal: Reducing the number of hot flushes per week
- Materials and Methods: A double-blind sulpiride versus placebo that includes selected randomized patients which show symptoms of menopause. The study will be conducted at HC Porto Alegre (Brazil) for 8 weeks of intervention. The expected result is a significant reduction in the number of hot flushes/day evaluated by daily questionnaires
详细描述
It will be held 4 visits. The V0 (first one) to implement the consent form, review the inclusion and exclusion criteria and laboratory exams and deliver the diary book of hot flushes. The V1 (second visit) randomization and provide medication for the first 30 days. The V2 (third visit) to make the record diary of hot flushes already filled, to deliver new specifications and to provide medication for the last 30 days. The V3 (fourth visit) to evaluate the record diary of hot flushes already completed and to make a final evaluation of the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women in postmenopausal women with at least five moderate to intense hot flushes per day
排除标准
- •Use of hormone replacement therapy or psychiatric drugs for at least 3 months
- •Hypersensitivity to sulpiride
- •Current or history of prolactin dependent tumor
- •Treating breast cancer or treated
- •Diagnosed or suspected pheochromocytoma
- •Current use of levodopa
- •Abnormal heart rhythm (QT prolongation, bradycardia low 55 beats per minute)
- •Hypokalemia and other serious electrolyte disturbances
- •Current or treated stroke
- •Pregnancy or breastfeeding
研究组 & 干预措施
Sulpiride use
50mg sulpiride once a day use for 60 days
干预措施: Sulpiride use (Drug)
Placebo
50mg placebo once a day use for 60 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number and severity records of hot flushes
时间窗: From baseline to eight weeks
Daily diary of symptoms
次要结局
未报告次要终点