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A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
1 other identifier
interventional
434
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2017
Typical duration for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedAugust 7, 2019
August 1, 2019
1.6 years
June 12, 2017
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Security assessments
Security assessments will include monitoring and recording all adverse events (AEs) and serious adverse events (SAEs).
Up to study completion at approximately 24 weeks
Changes of uterine fibroids(maximal fibroids)
Comparison of changes in the volume group of uterine fibroids (maximal fibroids)before and after treatment
Through study completion，an average of half year
Secondary Outcomes (5)
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
Evaluation of the uterine bleeding symptoms
Through study completion，an average of three months
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
Study Arms (3)
Mifepristone A group
EXPERIMENTALMifepristone tablets for 12 weeks with two follow-up
Mifepristone B group
EXPERIMENTALMifepristone tablets for 12 weeks with four follow-up
Mifepristone C group
EXPERIMENTALMifepristone tablets for 24 weeks with four follow-up
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
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
Related Publications (6)
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.
PMID: 24094421BACKGROUNDWang 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.
PMID: 11809103BACKGROUNDYang 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.
PMID: 9275461BACKGROUNDEisinger 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.
PMID: 12576246BACKGROUNDEisinger 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.
PMID: 15922980BACKGROUNDKulshrestha 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.
PMID: 23852296BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingfang Zhou, M.D.
Beijing Univesitay First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2017
First Posted
July 6, 2017
Study Start
June 1, 2017
Primary Completion
January 4, 2019
Study Completion
July 12, 2019
Last Updated
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share