NCT00240942已完成2 期
Letrozole in the Treatment of Severe and Recurrent Endometriosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks
研究概览
简要总结
Endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. This study will investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition effective in reducing measurable endometriosis lesions and in reducing pain in patients with active endometriosis which were pretreated with GnRH analogs for 2 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women > 18 years of age.
- •Laparoscopic and Histologically confirmed diagnosis of moderate or severe endometriosis according rASRM-Score III and IV
- •BMI less than 40 kg/m².
- •Patient is sexually abstinent or using mechanical (condoms, diaphragms) or sterilization methods of contraception and is willing to continue using them throughout the study.
- •Patient is willing and able to comply with study requirements.
- •Written informed consent.
排除标准
- •Endometriosis stage I-II acc. according to rASRM
- •Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
- •Significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range.
- •Patient desires pregnancy for the duration of the study, is pregnant or breast feeding.
- •GnRH therapy during the last 6 months
- •Use of hormonal contraception, selective estrogen receptor modulators, progestins, estrogens, steroids, or ovulation induction in the 4 weeks prior to inclusion into the study.
- •Untreated abnormal pap smear or other gynecologic condition.
- •History of venous thrombosis events including deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis.
- •History of stroke, complicated migraine, or documented transient ischemic attack.
- •Known hypersensitivity to any ingredient of the study medication.
- •Treatment with other aromatase inhibitors
- •Other investigational drugs within the past 30 days and the concomitant use of investigational drugs.
- •History of non-compliance to medical regimens, and patients who are considered potentially unreliable.
- •Additional protocol-defined inclusion / exclusion criteria may apply
结局指标
主要结局
Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks
次要结局
- Duration of clinical response
- Time to progression of the disease
- Correlation of tumour response with pretreatment ER/PR status
- Histological grade and aromatase levels
研究者
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