NCT01557179已完成2 期
Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness. A Multicenter, Randomized, Controlled, Open-label, Parallel-group, Clinical Trial
Lee's Pharmaceutical Limited0 个研究点目标入组 144 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- percentage of improvement of vaginal dryness symptoms
研究概览
简要总结
This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •under 70 years old,
- •had been naturally or surgically postmenopausal for more than 6 months,
- •had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen
排除标准
- •unmarried, pregnant and breast-feeding women,
- •patients with vaginal infections such as trichomonas,
- •candida and bacterial vaginosis,
- •patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
- •genital bleeding of unknown origin,
- •patients with acute hepatopathy, embolic disorders,
- •severe primary disease of the kidney and hematopoietic system
- •recent malignant tumors
结局指标
主要结局
percentage of improvement of vaginal dryness symptoms
时间窗: 30 days
percentage of improvement of vaginal dryness symptoms at the baseline and after treatment
次要结局
- percentage of improvement of itching, dyspareunia and burning sensation(30 days)
研究者
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