Clinical trial · Interventional
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
NCT03210324CI-TRIAL-00039911terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It is difficult to recruit enough participants
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mifepristone tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Mifepristone A group
- description
- Mifepristone tablets for 12 weeks with two follow-up
- interventionNames
- Drug: Mifepristone tablets
- type
- EXPERIMENTAL
- label
- Mifepristone B group
- description
- Mifepristone tablets for 12 weeks with four follow-up
- interventionNames
- Drug: Mifepristone tablets
- type
- EXPERIMENTAL
- label
- Mifepristone C group
- description
- Mifepristone tablets for 24 weeks with four follow-up
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDShen 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 24094421
- BACKGROUNDWang 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 11809103
- BACKGROUNDYang 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 9275461
- BACKGROUNDEisinger 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 12576246
- BACKGROUNDEisinger 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 15922980
- BACKGROUNDKulshrestha 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 23852296