NCT01486979已完成1 期
A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
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
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who are able to use German language in speaking and writing
- •Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
- •Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
- •Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
- •Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
- •Availability of a normal mammogram within one year prior to trial start
- •Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations
排除标准
- •Known or suspected allergy to trial product or related products
- •Known, suspected or past history of breast cancer
- •Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
- •Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
- •Abnormal genital bleeding of unknown etiology
- •Previous estrogen and/ or progestin hormone replacement therapy
研究组 & 干预措施
Low dose
Experimental
干预措施: estradiol, 10 mcg (Drug)
High dose
Active Comparator
干预措施: estradiol, 25 mcg (Drug)
结局指标
主要结局
Area under the curve (AUC)
次要结局
- Average plasma concentration (C average)
- Maximal concentration (Cmax)
- Minimal concentration (Cmin)
- Time of maximal concentration (tmax)
- Incidence of adverse events
研究者
研究点 (1)
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