A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
NCT ID: NCT03210324
Last Updated: 2019-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
434 participants
INTERVENTIONAL
2017-06-01
2019-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids
NCT00881140
The Effect of Mifepristone on Uterine Fibroids and Breast Tissue
NCT00579475
Mifepristone for Treatment of Uterine Fibroids
NCT00712595
Trial of Mifepristone for Fibroids
NCT00133705
Mifepristone to Treat Uterine Fibroids
NCT01786226
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mifepristone A group
Mifepristone tablets for 12 weeks with two follow-up
Mifepristone tablets
Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
Mifepristone B group
Mifepristone tablets for 12 weeks with four follow-up
Mifepristone tablets
Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
Mifepristone C group
Mifepristone tablets for 24 weeks with four follow-up
Mifepristone tablets
Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mifepristone tablets
Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
China Resources Zizhu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yingfang Zhou, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Univesitay First Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Maternal and Child Health Care Hospiatl of Capital Medical Hospital
Beijing, Beijing Municipality, China
Beijing University First Hospital
Beijing, Beijing Municipality, China
Fuling Center Hospital of Chongqing City
Chongqing, Chongqing Municipality, China
The Second Hospital of Chongqing Medical Universit
Chongqing, Chongqing Municipality, China
The Second Hospital of Logyan
Longyan, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Guangdong Hospital for Maternal amd Child Health Care
Guangdong, Guandong, China
The Third Affillated Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fouth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical Universty
Harbin, Heilongjiang, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 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
Changsha Hospital for Maternal amd Child Health Care
Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Weifang People's Hospital
Weifang, Shandong, China
Obstetrics and Gynecology Hospital of Fudan Universty
Shanghai, Shanghai Municipality, China
Shanghai TCM-INTEGATED Hospital,Shanghai University of TCM
Shanghai, Shanghai Municipality, China
Westnorth Matertal and Child Hospital
Xian, Shanxi, China
Yanan University Affillated Hospital
Yanan, 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 Municipality, China
Women's Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Shen Q, Hua Y, Jiang W, Zhang W, Chen M, Zhu X. Effects of mifepristone on uterine leiomyoma in premenopausal women: a meta-analysis. Fertil Steril. 2013 Dec;100(6):1722-6.e1-10. doi: 10.1016/j.fertnstert.2013.08.039. Epub 2013 Oct 2.
Wang H, Jin J. [Effects of mifepristone on estrogen and progestin receptors in human uterine leiomyoma]. Zhonghua Fu Chan Ke Za Zhi. 2000 Feb;35(2):79-81. Chinese.
Yang Y, Zheng S, Li K. [Treatment of uterine leiomyoma by two different doses of mifepristone]. Zhonghua Fu Chan Ke Za Zhi. 1996 Oct;31(10):624-6. Chinese.
Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5.
Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022.
Kulshrestha V, Kriplani A, Agarwal N, Sareen N, Garg P, Hari S, Thulkar J. Low dose mifepristone in medical management of uterine leiomyoma - an experience from a tertiary care hospital from north India. Indian J Med Res. 2013 Jun;137(6):1154-62.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZZYY-MF-10-401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.