The Effect of Toremifene Treatment to the Magnetic Resonance Imaging Findings in Women Suffering From Premenstrual Mastalgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- the effects to the MRI findings
研究概览
简要总结
The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia.
详细描述
Benign breast pain is a common complaint of women in western countries. As many as 41-69% of women reported having mastalgia sufficient to interfere with their daily routines. Approximately 8-10% of premenopausal women suffer monthly from moderate to severe breast pain.Tamoxifen has previously been found to be effective in reducing premenstrual mastalgia. We showed that another triphenylethylene derivative, toremifene, significantly alleviated cyclical breast pain as compared to placebo. In this study women suffering from cyclical breast pain are randomly allocated to receive toremifene (20mg) or placebo during the luteal phase for three consecutive cycles. The patients are then crossed over after a wash-out period to placebo or toremifene, respectively. The MRI investigations are made at two occasions during the premenstrual period after three cycles of toremifene and after three cycles of placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenstrual mastalgia
- •Age 20-45 years
- •Reliable non-hormonal contraception
排除标准
- •Pregnancy
- •Breast cancer or uterine corpus cancer
- •Unexplained menstrual disorders
- •Serious health problems
- •Hormonal contraception, including hormonal IUD trade name Mirena
- •Oestrogen and/or progestin treatment
- •Hysterectomy and/or oophorectomy or radiation therapy
- •Artificial cardiac pacemaker/metallic prostheses
研究组 & 干预措施
A placebo
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
干预措施: placebo (Drug)
B toremifene
The participants were randomly allocated to receive toremifene (20 mg) or placebo during the luteal phase for three consecutive menstrual cycles.
干预措施: toremifene (Drug)
结局指标
主要结局
the effects to the MRI findings
时间窗: after three cycles toremifene and placebo plus wash-out cycle, seven months
magnetic resonance imaging changes
时间窗: seven months
次要结局
- cyclic breast pain relief, quality of life, acceptability of treatment(seven months)
- breast pain(seven months)