A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 18
- 主要终点
- The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
研究概览
简要总结
The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg
详细描述
The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.
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
- 48 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Successful completion of study M00-198
- •Continued good general health
- •Negative urine pregnancy test
排除标准
- •History of known or suspected cancer other than basal cell carcinoma in last 5 years
- •History of reproductive endocrine disorder
- •Submucous or other symptomatic fibroid which would confound efficacy
- •Ovarian mass
- •Ongoing treatment with an excluded medication
- •Stenosis of the cervix
- •Any abnormal lab result the study-doctor considers significant.
研究组 & 干预措施
1
干预措施: Asoprisnil/Premarin (Drug)
结局指标
主要结局
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
时间窗: Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
时间窗: Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
时间窗: Months 3,6
次要结局
- Frequency and amount of vaginal bleeding assessed via daily diary.(Throughout study)
- Frequency and severity of hot flushes assessed via daily diary.(Throughout study)
- Mean change from baseline in endocrine determinations.(Months 2,4,and 6)
- Global efficacy question(Month 6)