NCT00465192已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 主要终点
- Relief of vaginal symptoms
研究概览
简要总结
This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy
- •Postmenopausal
- •Hysterectomized or non-hysterectomized
- •Moderate or severe vaginal dryness and soreness
排除标准
- •Known, suspected, or past history of breast cancer
- •Known, suspected, or past history of hormone-dependent tumor
- •Genital bleeding of unknown etiology
- •Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
- •Vaginal infection
- •Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
- •Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
- •History of treatment with diethylstilbestrol
结局指标
主要结局
Relief of vaginal symptoms
时间窗: following 12 weeks of treatment.
次要结局
- Hematology and chemisty tests, and endometrial biopsy
- Vaginal and urethral cytology, and grading of vaginal health
- Adverse events
研究者
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