Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 434
- 试验地点
- 26
- 主要终点
- Security assessments
研究概览
简要总结
To investigate the efficacy and adverse effects of mifepristone tablets in widely used conditions, to evaluate the relationship between interests and risks used in general or special populations, to further observe the safety and efficacy of drugs.
详细描述
Uterine fibroids (also referred to as myomas, leiomyomas, leiomyomata, and fibromyomas) are non-cancerous (benign) tumors that grow within the muscle tissue of the uterus. Approximately 20-40% of women 35 years and older have fibroids. While many women with fibroids do not experience any symptoms, the location and size of fibroids can cause symptoms that can affect a woman's quality of life.
Fibroids are hormonally sensitive so symptoms are likely to be cyclical with menstruation. Fibroid growth is dependent on hormone levels; an increase in a woman's hormone levels may cause the size of fibroids to increase. During menopause, these hormones decrease dramatically and may cause fibroid symptoms to diminish.
Mifepristone is an antiestrogen hormone that antagonizes progesterone at receptor levels. Estrogen is generally considered to be a major contributor to uterine fibroids, but many studies have confirmed that progesterone can promote fibroid cell mitosis, and thus promote fibroids growth. In recent years, domestic and international clinical studies have shown that mifepristone treatment for 3 months can significantly reduce the size of uterine fibroids to achieve complete amenorrhea, improve bleeding caused by anemia, reduce clinical symptoms, uterine fibroids to reduce the size of complex Of the hysterectomy surgery into a simple, to avoid surgery caused by other organs of the injury, shorten the operation time, reduce the amount of surgical bleeding and blood transfusion, so that patients recover faster after surgery The literature reported the clinical use of 50mg, 25mg, 10mg and 5mg. The minimum dose of 10mg daily, 3 months can reduce the average size of uterine fibroids nearly half. Daily 5mg on fibroids shrink is not obvious. Mifepristone tablets is developed by the China Resources Zizhu Pharmaceutical Co., Ltd. Drugs and Drugs 1.6, each tablet 10mg, for adult age women have moderate to severe symptoms of uterine fibroids before the treatment of national food and drug supervision and management General Administration of the People 's Republic of China on October 24, 2014 approved its listing, the drug registration approval number: 2014S00506. According to the State Food and Drug Administration drug clinical approval requirements of this product need to carry out IV clinical research, the purpose is to examine the efficacy of drugs in a wide range of conditions and adverse reactions to evaluate the general or special population in the use of the interests and risks , To further observe the safety and efficacy of drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
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
- •In line with the diagnosis of uterine fibroids;
- •With fibroids associated with clinical symptoms (such as uterine bleeding symptoms, symptoms of oppression, pain symptoms, etc.); or nearly 3 months fibroids gradually grow; or the largest fibroid diameter ≥ 5cm;
- •Women of childbearing age over 18 years of age;
- •Voluntarily tested and signed informed consent
排除标准
- •Unexplained or vaginal bleeding other than uterine fibroids;
- •Combined with malignant tumors (including reproductive and other systems), or endometrial ≥ 17mm;
- •Is the use of simple progesterone contraceptives, progesterone-containing intrauterine device or compound oral contraceptives;
- •Is using ketoconazole, itraconazole, erythromycin, rifampicin, adrenocorticotropic hormone (hydrocortisone, prednisone, dexamethasone, etc.), and some anticonvulsants (phenytoin, Phenobarbital, carbamazepine), griseofulvin, nonsteroidal antiinflammatory drugs (aspirin, acetaminophen, ibuprofen, etc.) and can not be discontinued during the study;
- •Pregnant women and lactating women and medication or medication within 3 months after the cessation of births;
- •Severe heart, liver, kidney disease and adrenal insufficiency, and / or ALT, AST> 1.5 times the upper limit of normal, Cr> normal upper limit;
- •Allergies or previous allergy to a variety of drugs, or the study of active ingredients in the medication or any excipient allergy;
- •Patients who have participated in other clinical trials within 3 months;
- •Other investigators who are not considered to be involved in this study.
研究组 & 干预措施
Mifepristone A group
Mifepristone tablets for 12 weeks with two follow-up
干预措施: Mifepristone tablets (Drug)
Mifepristone B group
Mifepristone tablets for 12 weeks with four follow-up
干预措施: Mifepristone tablets (Drug)
Mifepristone C group
Mifepristone tablets for 24 weeks with four follow-up
干预措施: Mifepristone tablets (Drug)
结局指标
主要结局
Security assessments
时间窗: Up to study completion at approximately 24 weeks
Security assessments will include monitoring and recording all adverse events (AEs) and serious adverse events (SAEs).
Changes of uterine fibroids(maximal fibroids)
时间窗: Through study completion，an average of half year
Comparison of changes in the volume group of uterine fibroids (maximal fibroids)before and after treatment
次要结局
- Evaluation of the uterine bleeding symptoms(Through study completion，an average of three months)
- Comparison of changes in the uterine volume(Through study completion，an average of half year)
- Comparison of the relevant indicators of anemia(Through study completion，an average of half year)
- Operation situation(Perioperative transfusion improvement,Type of surgery)(Through study completion，an average of half year)
- Clinical symptom scores(Through study completion，an average of half year)