NCT00464971已完成3 期
Evaluation of Safety and Efficacy of 17-Beta Estradiol 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
- 102
- 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 to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Successful completion of the study VAG/PD/009/USA
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
- •Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
- •Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days
结局指标
主要结局
Relief of vaginal symptoms
时间窗: over 12 months of treatment
Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
次要结局
- Vaginal health, vaginal cytology and urethral cytology
研究者
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