A Phase II Pilot Study to Evaluate the Safety and Efficacy 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
- 105
- 主要终点
- Assessment of endometrium by endometrial biopsy
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.
详细描述
The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Postmenopausal women with an intact uterus
- •Body mass index (BMI) between 18.0 - 33.0
- •Good general health
- •Endometrial thickness ≤ 4 mm by TVU
- •No history or suspected endometrial hyperplasia
- •Negative urine pregnancy test
- •Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes
- •Mammogram without suspicion of malignancy within last 6 months
- •Endometrial biopsy with no evidence of pathologic changes within last 6 months
排除标准
- •Any abnormal lab result the study-doctor considers significant
- •History of severe reaction to hormone therapy
- •Receiving hormone therapy
- •Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones
- •History or known or suspected cancer other than basal cell carcinoma
- •Stenosis of the cervix
- •History of reproductive endocrine disorder
- •Washout requirement for hormonal therapy not met
- •Ovarian mass
- •Submucus or other symptomatic fibroid which would confound efficacy
研究组 & 干预措施
3
干预措施: Asoprisnil/Premarin (Drug)
1
干预措施: Asoprisnil/Premarin (Drug)
2
干预措施: Asoprisnil/Premarin (Drug)
4
干预措施: Placebo and Premarin (Drug)
结局指标
主要结局
Assessment of endometrium by endometrial biopsy
时间窗: Week 12
Change from baseline in endometrial thickness as assessed by ultrasound
时间窗: Week 12
次要结局
- Frequency and amount of vaginal bleeding via patient diary.(Week 4, 8, and 12)
- Incidence of hot flushes(Week 4, 8, and 12)
- Presence or absence of endometrial hyperplasia.(Week 12)
- Response to global efficacy question regarding improvement in menopause symptoms.(Week 12)