Clinical trial NCT03210324: A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
Official title: Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Uterine Fibroid
Keywords: mifepristone antiprogestins
Lead sponsor: China Resources Zizhu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 434
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Security assessments
timeFrame: Up to study completion at approximately 24 weeks
measure: Changes of uterine fibroids(maximal fibroids)
timeFrame: Through study completion，an average of half year
Secondary outcomes:
measure: Comparison of changes in the uterine volume
timeFrame: Through study completion，an average of half year
measure: Comparison of the relevant indicators of anemia
timeFrame: Through study completion，an average of half year
measure: Evaluation of the uterine bleeding symptoms
timeFrame: Through study completion，an average of three months
measure: Operation situation(Perioperative transfusion improvement,Type of surgery)
timeFrame: Through study completion，an average of half year
measure: Clinical symptom scores
timeFrame: Through study completion，an average of half year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Maternal and Child Health Care Hospiatl of Capital Medical Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing University First Hospital
state: Beijing
city: Chongqing
country: China
facility: Fuling Center Hospital of Chongqing City
state: Chongqing
city: Chongqing
country: China
facility: The Second Hospital of Chongqing Medical Universit
state: Chongqing
city: Longyan
country: China
facility: The Second Hospital of Logyan
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Guangdong
country: China
facility: Guangdong Hospital for Maternal amd Child Health Care
state: Guandong
city: Guangzhou
country: China
facility: The Third Affillated Hospital of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Fouth Hospital of Shijiazhuang
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical Universty
state: Heilongjiang
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Zhengzhou
country: China
facility: The Second Affillated Hoapital of Zhenghzou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong Universty of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Changsha Hospital for Maternal amd Child Health Care
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan Universty
state: Shanghai
city: Shanghai
country: China
facility: Shanghai TCM-INTEGATED Hospital,Shanghai University of TCM
state: Shanghai
city: Xian
country: China
facility: Westnorth Matertal and Child Hospital
state: Shanxi
city: Yanan
country: China
facility: Yanan University Affillated Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chendu Third Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Women and Chirdren's Central Hosptal
state: Sichuan
city: Mianyang
country: China
facility: Mianyan Central Hospital
state: Sichuan
city: Yibin
country: China
facility: The First People's Hospital of Yibin
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Central Hoapital of Gynecology Obstetrics
state: Tianjin
city: Hangzhou
country: China
facility: Women's Hospital of Zhejiang Medical University
state: Zhejiang
Study officials:
affiliation: Beijing Univesitay First Hospital
name: Yingfang Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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. doi: 10.1016/s0029-7844(02)02511-5.
citation: 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.
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.