NCT00607295已完成3 期
Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- vaginal dryness score
研究概览
简要总结
- Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
- "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
- We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer patients
- •who are treated with chemotherapy or hormonal therapy
- •who experience no menstruation after the previous therapy
- •who complain of vaginal dryness
排除标准
- •other cancer patients
- •other severe disease
- •poor compliance
研究组 & 干预措施
1
Experimental
Clino-san 2ml vaginal application 3 times per week for 12 weeks
干预措施: clino-san vaginal lubricant (Drug)
2
Placebo Comparator
placebo 2ml vaginal application 3 times per week for 12 weeks
干预措施: clino-san vaginal lubricant (Drug)
结局指标
主要结局
vaginal dryness score
时间窗: for 12 weeks
次要结局
- sexual dysfunction(for 12 weeks)
研究者
研究点 (1)
Loading locations...
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