A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 33
- 主要终点
- Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
研究概览
简要总结
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.
详细描述
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women, at least 18 years of age
- •Diagnosis of uterine fibroid(s), confirmed by ultrasound
- •History of menstrual cycles between 17 and 42 days
- •Otherwise in good health
- •Scheduled for a hysterectomy at the end of the treatment period
- •Negative pregnancy test
- •Agrees to double barrier method of contraception
- •Pap test with no evidence of malignancy or pre-malignant changes
- •Endometrial biopsy with no significant histological disorder
排除标准
- •Less than 3 months after having a baby or breast-feeding
- •Any abnormal lab or procedure result the study-doctor considers important
- •Severe reaction(s) to or are currently using any hormone therapy
- •History of cancer or alcohol or drug abuse
- •Diagnosis of Polycystic Ovary Syndrome
- •History of prolactinoma
- •Current use of Intrauterine Device
- •Significant gynecological disorder
- •Uterine size > 32 weeks gestation
- •Current diagnosis of endometriosis
- •Uterine artery embolization within 6 months
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: Placebo (Drug)
结局指标
主要结局
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
时间窗: Final visit
次要结局
- Percent change from baseline in volume of the largest fibroid.(Final Visit)
- Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.(Final Visit)
- Morphological changes in the endometrium, myometrium and uterine fibroids.(Final Visit)
- Change from baseline in menstrual pictogram score.(Final Month)
- Endometrial thickness (post-treatment histologic evaluation).(Final Visit)
- Change from baseline in endometrial thickness by transvaginal ultrasound.(Final Visit)
- Percent of ovulatory subjects.(Final Month)
- Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.(Final Visit)