Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change of Pain Score of Female Sexual Function Index
研究概览
简要总结
The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.
详细描述
Study scheme
- study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks
- control arm: placebo apply
Outcome measures
- Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk
- vaginal maturation index: at 0 wk and 8 wk
- vaginal pH: at 0 wk and 8 wk
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer survivors over 20 years-old
- •premenopausal at the time of diagnosis
- •treated with operation and chemotherapy
- •newly developed dyspareunia after cancer treatment
排除标准
- •recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)
- •depression or other psychological problems
- •active vaginal infection
- •evidence of cancer recurrence
- •previously use of lactate-containing lubricants
- •other chronic diseases which severely disturb the sexual life
研究组 & 干预措施
Lactate-containing Vaginal Lubricant
apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
干预措施: Lactate-containing vaginal lubricant (Drug)
Placebo
apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)
干预措施: Placebo vaginal lubricant (Drug)
结局指标
主要结局
Change of Pain Score of Female Sexual Function Index
时间窗: Baseline and 8 weeks
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
次要结局
- Change of a Total and Other Five Domains of Female Sexual Function Index Score(Baseline and 8 weeks)
- Change of Vaginal pH(Baseline and 8 weeks)
- Change of Vaginal Maturation Index(Baseline and 8 weeks)