NCT00195520已完成4 期
An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
Wyeth is now a wholly owned subsidiary of Pfizer2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
研究概览
简要总结
To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Intact uterus
- •Generally health postmenopausal women 45 to 60 years of age, inclusive
- •Sexually active
- •No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.
排除标准
- •Known or suspect estrogen-dependent neoplasia
- •Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
- •Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.
结局指标
主要结局
To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
次要结局
- To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
研究者
研究点 (2)
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