A Phase II Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of J867 Administered in Patients With Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 130
- 主要终点
- Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.
详细描述
Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the safety and efficacy of asoprisnil 5, 10, and 25 mg tablets, compared to placebo, administered daily for 12 weeks to women with endometriosis, by assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea, dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens the subjects' perceived pain symptoms. Otherwise healthy women with surgically confirmed endometriosis will be enrolled.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Surgically confirmed endometriosis
- •History of menstrual cycles between 26 and 32 days
- •Otherwise in good health
- •Age 18-40 years, inclusive
- •Subject had pain graded at Screening and Day 1 according to a scale suggested by Biberoglu and Berhman5 in at least one of the following categories:
- •moderate or severe pelvic pain not related to menstruation, OR
- •moderate or severe dysmenorrhea, OR
- •moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain.
- •Subject agrees to double barrier method of contraception
排除标准
- •Any abnormal lab or procedure result the study-doctor considers important
- •History of undiagnosed uterine bleeding or gynecological disorder
- •Severe reaction(s) to hormone therapy
- •History of osteoporosis or other metabolic bone disease
- •Subject currently breast feeding
研究组 & 干预措施
1
干预措施: Asoprisnil (Drug)
2
干预措施: Asoprisnil (Drug)
3
干预措施: Asoprisnil (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary
时间窗: Mean change from baseline to Months 1, 2, 3
次要结局
- Global efficacy question(Final visit)
- Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale(Each monthly visit)