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

• Status: Terminated
• Trial end date: 2019-07-12
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Resources Zizhu Pharmaceutical Co., Ltd.
• Treatments: Mifepristone

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.