A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
- Registration Number
- NCT03210324
- Lead Sponsor
- China Resources Zizhu Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 434
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mifepristone B group Mifepristone tablets Mifepristone tablets for 12 weeks with four follow-up Mifepristone A group Mifepristone tablets Mifepristone tablets for 12 weeks with two follow-up Mifepristone C group Mifepristone tablets Mifepristone tablets for 24 weeks with four follow-up
- Primary Outcome Measures
Name Time Method Security assessments 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) Through study completion，an average of half year Comparison of changes in the volume group of uterine fibroids (maximal fibroids)before and after treatment
- Secondary Outcome Measures
Name Time Method Evaluation of the uterine bleeding symptoms Through study completion，an average of three months The uterine bleeding symptoms were recorded before treatment.
Comparison of changes in the uterine volume Through study completion，an average of half year Comparison of changes in the uterine volume before and after treatment.
Comparison of the relevant indicators of anemia Through study completion，an average of half year Before and after treatment on the relevant indicators of anemia(red blood cell count, erythrocyte ratio, hemoglobin) groups of visits to the relative baseline changes in the value of the description, the group comparison.
Operation situation(Perioperative transfusion improvement,Type of surgery) Through study completion，an average of half year When surgery was occurred, recording perioperative blood transfusion values; if the operation was performed, the proportion of subjects using minimally invasive surgery was calculated for all subjects.
Clinical symptom scores Through study completion，an average of half year The clinical symptom scores were recorded before treatment.
Trial Locations
- Locations (26)
The Third Affillated Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Fuling Center Hospital of Chongqing City
🇨🇳Chongqing, Chongqing, China
The Fouth Hospital of Shijiazhuang
🇨🇳Shijiazhuang, Hebei, China
The Second Hospital of Chongqing Medical Universit
🇨🇳Chongqing, Chongqing, China
The Second Hospital of Logyan
🇨🇳Longyan, Fujian, China
The Second Affillated Hoapital of Zhenghzou University
🇨🇳Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College of Huazhong Universty of Science and Technology
🇨🇳Wuhan, Hubei, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Beijing Maternal and Child Health Care Hospiatl of Capital Medical Hospital
🇨🇳Beijing, Beijing, China
Beijing University First Hospital
🇨🇳Beijing, Beijing, China
Quanzhou First Hospital
🇨🇳Quanzhou, Fujian, China
Guangdong Hospital for Maternal amd Child Health Care
🇨🇳Guangdong, Guandong, China
The Second Affiliated Hospital of Harbin Medical Universty
🇨🇳Harbin, Heilongjiang, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
Changsha Hospital for Maternal amd Child Health Care
🇨🇳Changsha, Hunan, China
Obstetrics and Gynecology Hospital of Fudan Universty
🇨🇳Shanghai, Shanghai, China
Yanan University Affillated Hospital
🇨🇳Yanan, Shanxi, China
Shanghai TCM-INTEGATED Hospital,Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China
Westnorth Matertal and Child Hospital
🇨🇳Xian, Shanxi, China
Chendu Third Hospital
🇨🇳Chengdu, Sichuan, China
Chengdu Women and Chirdren's Central Hosptal
🇨🇳Chengdu, Sichuan, China
Mianyan Central Hospital
🇨🇳Mianyang, Sichuan, China
The First People's Hospital of Yibin
🇨🇳Yibin, Sichuan, China
Tianjin Central Hoapital of Gynecology Obstetrics
🇨🇳Tianjin, Tianjin, China
Women's Hospital of Zhejiang Medical University
🇨🇳Hangzhou, Zhejiang, China