Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial.
详细描述
For women who fear developing breast cancer, those who have contraindications to hormone replacement therapy and those who prefer an alternative treatment, there is presently no standard treatment for hot flashes. Women and health care providers have few options other than hormone replacement therapy as evidenced-based trials of alternatives have not shown many effective options. Many non-hormonal agents have been studied including antidepressants, antihypertensives, vitamin E, soy products, black cohosh, acupuncture, and belladonna and ergotamine combinations. Preliminary studies using the antiseizure medication, gabapentin (Neurontin), has demonstrated a substantial reduction in hot flashes. This agent may provide an effective treatment for hot flashes in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with substantial hot flashes defined as reporting at least 14 hot flashes per week.
- •Postmenopausal women as defined by the natural cessation of menses for 1 year.
- •Aged 45 - 65 years.
排除标准
- •Women on hormone replacement therapy.
- •Women with a surgically induced menopause (oophorectomy).
- •Women on tamoxifen or receiving chemotherapy/radiation therapy or planned antineoplastic chemotherapy/radiation therapy.
- •Renal function impairment (serum creatinine greater than the laboratory normal range; or creatinine clearance <30ml/min).
- •Use of antidepressants with serotonin reuptake mechanisms and antiseizure medications within the past month.
- •Neurologic conditions: seizures, vertigo, and syncope.
- •Known hypersensitivity to gabapentin and its components.
- •Inability to complete questionnaires for any reason including psychiatric disorders.
- •History of a hypothalamic dysfunction.
- •Life expectancy less than 6 months.
结局指标
主要结局
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
次要结局
- The toxicity profile of gabapentin in this population compared with placebo
- The impact of gabapentin on quality of life in this population compared with placebo
- Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores