Uterine FibroidPhase 4NCT03210324
A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy
A Phase 4 study testing Mifepristone tablets in people with Uterine Fibroid, run by China Resources Zizhu Pharmaceutical Co., Ltd. at 26 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- Mifepristone tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 26 sitesChina
- Study dates
- 1 Jun 2017to 12 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Beijing Maternal and Child Health Care Hospiatl of Capital Medical Hospital
Beijing, Beijing Municipality
Beijing University First Hospital
Beijing, Beijing Municipality
Changsha Hospital for Maternal amd Child Health Care
Changsha, Hunan
Chendu Third Hospital
Chengdu, Sichuan
Chengdu Women and Chirdren's Central Hosptal
Chengdu, Sichuan
Fuling Center Hospital of Chongqing City
Chongqing, Chongqing Municipality
The Second Hospital of Chongqing Medical Universit
Chongqing, Chongqing Municipality
Guangdong Hospital for Maternal amd Child Health Care
Guangdong, Guandong
The Third Affillated Hospital of Southern Medical University
Guangzhou, Guangdong
Women's Hospital of Zhejiang Medical University
Hangzhou, Zhejiang
The Second Affiliated Hospital of Harbin Medical Universty
Harbin, Heilongjiang
Huaihe Hospital of Henan University
Kaifeng, Henan
The Second Hospital of Logyan
Longyan, Fujian
Mianyan Central Hospital
Mianyang, Sichuan
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi
Quanzhou First Hospital
Quanzhou, Fujian
Obstetrics and Gynecology Hospital of Fudan Universty
Shanghai, Shanghai Municipality
Shanghai TCM-INTEGATED Hospital,Shanghai University of TCM
Shanghai, Shanghai Municipality
The Fouth Hospital of Shijiazhuang
Shijiazhuang, Hebei
Tianjin Central Hoapital of Gynecology Obstetrics
Tianjin, Tianjin Municipality
Weifang People's Hospital
Weifang, Shandong
Tongji Hospital of Tongji Medical College of Huazhong Universty of Science and Technology
Wuhan, Hubei
Westnorth Matertal and Child Hospital
Xian, Shanxi
Yanan University Affillated Hospital
Yanan, Shanxi
The First People's Hospital of Yibin
Yibin, Sichuan
The Second Affillated Hoapital of Zhenghzou University
Zhengzhou, Henan
About this study
Official title: Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
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.
Read the 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.
- Conditions
- Uterine Fibroid
- Being tested
- Mifepristone tablets
- Keywords
- mifepristone antiprogestins
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone A group | Experimental | Mifepristone tablets for 12 weeks with two follow-up Receives: Drug: Mifepristone tablets |
| Mifepristone B group | Experimental | Mifepristone tablets for 12 weeks with four follow-up Receives: Drug: Mifepristone tablets |
| Mifepristone C group | Experimental | Mifepristone tablets for 24 weeks with four follow-up Receives: Drug: Mifepristone tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security assessments
Security assessments will include monitoring and recording all adverse events (AEs) and serious adverse events (SAEs).
Measured: Up to study completion at approximately 24 weeks
Changes of uterine fibroids(maximal fibroids)
Comparison of changes in the volume group of uterine fibroids (maximal fibroids)before and after treatment
Measured: Through study completion，an average of half year
Secondary outcomes (5)
Comparison of changes in the uterine volume
Comparison of changes in the uterine volume before and after treatment.
Measured: Through study completion，an average of half year
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.
Measured: Through study completion，an average of half year
Evaluation of the uterine bleeding symptoms
The uterine bleeding symptoms were recorded before treatment.
Measured: Through study completion，an average of three months
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.
Measured: Through study completion，an average of half year
Clinical symptom scores
The clinical symptom scores were recorded before treatment.
Measured: Through study completion，an average of half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Jun 2017
- Primary completion4 Jan 2019
- Study completion12 Jul 2019
Why it stopped: It is difficult to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Resources Zizhu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yingfang Zhou, M.D., Principal investigator, Beijing Univesitay First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210324
- Sponsor's protocol ID
- ZZYY-MF-10-401
- Status last verified
- Aug 2019
- First submitted
- 12 Jun 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24094421Wang 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.
PubMed 11809103Yang 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.
PubMed 9275461Eisinger 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.
PubMed 12576246Eisinger 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.
PubMed 15922980Kulshrestha 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.
PubMed 23852296
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy in Open, Multicenter Phase IV Clinical Studies
- ClinicalTrials.gov ID
- NCT03210324
- Acronym / sponsor ID
- ZZYY-MF-10-401
- Conditions
- Uterine Fibroid
- Keywords
- mifepristone antiprogestins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is difficult to recruit enough participants
- Enrolment
- 434 participants (actual)
- Lead sponsor
- China Resources Zizhu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mifepristone A group | Experimental | Drug: Mifepristone tabletsMifepristone tablets for 12 weeks with two follow-up |
| Mifepristone B group | Experimental | Drug: Mifepristone tabletsMifepristone tablets for 12 weeks with four follow-up |
| Mifepristone C group | Experimental | Drug: Mifepristone tabletsMifepristone tablets for 24 weeks with four follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone tabletsDaily 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. | Drug | Mifepristone A group, Mifepristone B group, Mifepristone C group |
Primary outcome
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).
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
5 secondary outcomes
Comparison of changes in the uterine volume
Time frame: Through study completion，an average of half year
Comparison of the relevant indicators of anemia
Time frame: Through study completion，an average of half year
Evaluation of the uterine bleeding symptoms
Time frame: Through study completion，an average of three months
Operation situation(Perioperative transfusion improvement,Type of surgery)
Time frame: Through study completion，an average of half year
Clinical symptom scores
Time frame: Through study completion，an average of half year
Results and safety
The study was stopped early (reason given: It is difficult to recruit enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 24094421Shen 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.
- Background: PubMed 11809103Wang 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.
- Background: PubMed 9275461Yang 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.
- Background: PubMed 12576246Eisinger 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.
- Background: PubMed 15922980Eisinger 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.
- Background: PubMed 23852296Kulshrestha 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.
- Individual participant dataSharing planned: No
Related trials for Uterine Fibroid
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingfang Zhou, M.D. principal investigator
Beijing Univesitay First Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone tablets in people with Uterine Fibroid, run by China Resources Zizhu Pharmaceutical Co., Ltd. at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It is difficult to recruit enough participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Security assessments (time frame: Up to study completion at approximately 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210324, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.