A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy

Uterine Fibroid Clinical Trial

Official title:

Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03210324
• Other study ID #: ZZYY-MF-10-401
• Status: Terminated
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: August 2019
• Source: China Resources Zizhu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 434
• Est. completion date: July 12, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Maternal and Child Health Care Hospiatl of Capital Medical Hospital	Beijing	Beijing
China	Beijing University First Hospital	Beijing	Beijing
China	Changsha Hospital for Maternal amd Child Health Care	Changsha	Hunan
China	Chendu Third Hospital	Chengdu	Sichuan
China	Chengdu Women and Chirdren's Central Hosptal	Chengdu	Sichuan
China	Fuling Center Hospital of Chongqing City	Chongqing	Chongqing
China	The Second Hospital of Chongqing Medical Universit	Chongqing	Chongqing
China	Guangdong Hospital for Maternal amd Child Health Care	Guangdong	Guandong
China	The Third Affillated Hospital of Southern Medical University	Guangzhou	Guangdong
China	Women's Hospital of Zhejiang Medical University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Harbin Medical Universty	Harbin	Heilongjiang
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	The Second Hospital of Logyan	Longyan	Fujian
China	Mianyan Central Hospital	Mianyang	Sichuan
China	Jiangxi Maternal and Child Health Hospital	Nanchang	Jiangxi
China	Quanzhou First Hospital	Quanzhou	Fujian
China	Obstetrics and Gynecology Hospital of Fudan Universty	Shanghai	Shanghai
China	Shanghai TCM-INTEGATED Hospital,Shanghai University of TCM	Shanghai	Shanghai
China	The Fouth Hospital of Shijiazhuang	Shijiazhuang	Hebei
China	Tianjin Central Hoapital of Gynecology Obstetrics	Tianjin	Tianjin
China	Weifang People's Hospital	Weifang	Shandong
China	Tongji Hospital of Tongji Medical College of Huazhong Universty of Science and Technology	Wuhan	Hubei
China	Westnorth Matertal and Child Hospital	Xian	Shanxi
China	Yanan University Affillated Hospital	Yanan	Shanxi
China	The First People's Hospital of Yibin	Yibin	Sichuan
China	The Second Affillated Hoapital of Zhenghzou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
China Resources Zizhu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Comparison of changes in the uterine volume	Comparison of changes in the uterine volume before and after treatment.	Through study completion,an average of half year
Secondary	Comparison of the relevant indicators of anemia	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.	Through study completion,an average of half year
Secondary	Evaluation of the uterine bleeding symptoms	The uterine bleeding symptoms were recorded before treatment.	Through study completion,an average of three months
Secondary	Operation situation(Perioperative transfusion improvement,Type of surgery)	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.	Through study completion,an average of half year
Secondary	Clinical symptom scores	The clinical symptom scores were recorded before treatment.	Through study completion,an average of half year