NCT01724242撤回2 期
Vaginal DHEA to Ease Vaginal Dryness in Women With a Contraindication to Estrogen Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- improvement in vaginal dryness
研究概览
简要总结
There does not appear to be a consensus regarding the treatment of vaginal dryness in women who have a contraindication to the use of estrogen products. DHEA, when used locally, may improve the symptoms of vaginal dryness due to its chemical properties.
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
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women post menopausal aged 35-55, suffering from vaginal dryness, secondary to chemotherapy for breast cancer, within 5 years of diagnosis. Follicle Stimulating Hormone and Estradiol levels in the post menopausal range are needed.
排除标准
- •women using products to alleviate vaginal dryness.
- •women taking medication for urinary incontinence
- •women not sexually active, for other reasons.
研究组 & 干预措施
Vaginal DHEA
Experimental
Vaginal DHEA 0.5%(6.5mg)inserted nightly
干预措施: Vaginal DHEA (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
improvement in vaginal dryness
时间窗: 12 weeks
次要结局
- improvement in urinary incontinence(12 weeks)
- improvement in sexual satisfaction(12 weeks)
研究者
研究点 (1)
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