JPRN-jRCT2080222591未知3 期
MJR-35 phase 3 study to investigate the efficacy and safety in patients with adenomyosis (a multicenter, randomized, double-blind, placebo-controlled, parallel-group study)
试验速览
- 阶段
- 3 期
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •(1) Patients who have a painful symptom (lower abdominal pain or lumber pain) that were considered to be originated in adenomyosis in a degree of 3 points or more of pain score
- •(2) Patients diagnosed with adenomyosis by means of imaging analysis using both transvaginal sonography and magnetic resonance imaging
排除标准
- •(1) Patients diagnosed with either endometriosis or uterine leiomyoma using both transvaginal sonography and magnetic resonance imaging
- •(2) Patients with a history or complication of severe anemia (hemoglobin less than 8.0 g/dL) due to adenomyosis
- •(3) Patients with anemia (hemoglobin from 8.0 to just under 11.0 g/dL) showing insufficient restoration (hemoglobin less than 11.0 g/dL) after the treatment of anemia
- •(4) Patients with a remarkable uterus swelling (100 mm or more in the greatest dimension or 40 mm or more in the maximal myometrial thickness) diagnosed by transvaginal sonography
- •(5) Patient with undiagnosed abnormal genital bleeding, endometrial polyp, or endometrial hyperplasia
研究者
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