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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210324
Recruitment Status : Terminated (It is difficult to recruit enough participants)
First Posted : July 6, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
China Resources Zizhu Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroid Drug: Mifepristone tablets Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : January 4, 2019
Actual Study Completion Date : July 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mifepristone A group
Mifepristone tablets for 12 weeks with two follow-up
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.

Experimental: Mifepristone B group
Mifepristone tablets for 12 weeks with four follow-up
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.

Experimental: Mifepristone C group
Mifepristone tablets for 24 weeks with four follow-up
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.




Primary Outcome Measures :
  1. Security assessments [ Time Frame: Up to study completion at approximately 24 weeks ]
    Security assessments will include monitoring and recording all adverse events (AEs) and serious adverse events (SAEs).

  2. Changes of uterine fibroids(maximal fibroids) [ Time Frame: Through study completion,an average of half year ]
    Comparison of changes in the volume group of uterine fibroids (maximal fibroids)before and after treatment


Secondary Outcome Measures :
  1. Comparison of changes in the uterine volume [ Time Frame: Through study completion,an average of half year ]
    Comparison of changes in the uterine volume before and after treatment.

  2. Comparison of the relevant indicators of anemia [ Time Frame: Through study completion,an average of half year ]
    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.

  3. Evaluation of the uterine bleeding symptoms [ Time Frame: Through study completion,an average of three months ]
    The uterine bleeding symptoms were recorded before treatment.

  4. Operation situation(Perioperative transfusion improvement,Type of surgery) [ Time Frame: Through study completion,an average of half year ]
    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.

  5. Clinical symptom scores [ Time Frame: Through study completion,an average of half year ]
    The clinical symptom scores were recorded before treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210324


Locations
Show Show 26 study locations
Sponsors and Collaborators
China Resources Zizhu Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Yingfang Zhou, M.D. Beijing Univesitay First Hospital
Publications:
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Responsible Party: China Resources Zizhu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03210324    
Other Study ID Numbers: ZZYY-MF-10-401
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Resources Zizhu Pharmaceutical Co., Ltd.:
mifepristone antiprogestins
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents