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| Name | Class |
|---|---|
| Anhui Province Cancer Hospital | UNKNOWN |
| Huzhou Maternity and Child Care Hospital | UNKNOWN |
| Jiaxing Maternity and Child Health Care Hospital | OTHER |
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This clinical trial is designed to study the effectiveness and safety of mifepristone in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. This multicenter study is performed in 150 subjects who are diagnosed as adenomyosis . Twelve weeks of randomization, allocation concealment, double-blind, placebo-controlled, parallel grouping. Subjects are randomly assigned to one of two treatment groups and received one of the following treatments:
Adenomyosis is a common benign disease of Gynecology, with secondary progressive dysmenorrhea and menorrhagia as the main clinical manifestations, which seriously harm the physical and mental health of the patients. Most patients have the desire to retain the uterus. Therefore, the treatment of drug conservative treatment is dominant in the treatment of adenomyosis. However, the current clinical treatment of adenomyosis still has some limitations and needs to be improved. Therefore, it is imperative to expand the clinical medication of adenomyosis.
Mifepristone is defined as a selective progesterone receptor modulator. Under specific conditions, it plays the role of anti progestin, inhibits endometrial proliferation, inhibits ovulation, and can cause reversible amenorrhea. In recent years, it has been widely used in of uterine leiomyoma and endometriosis. Adenomyosis is also closely related to hormone related diseases, especially endometriosis. At present, the study of mifepristone in the treatment of adenomyosis is more extensive in China. A large number of domestic literature reports that low dose mifepristone for the treatment of adenomyosis is safe and effective for the treatment of adenomyosis . During the treatment of mifepristone, most of the patients had amenorrhea, obviously alleviating dysmenorrhea and reducing the menstrual volume, reducing the uterine and lesion volume of the patients with adenomyosis . However, most of the domestic literature is a small sample case control study or retrospective study. There is no randomized double blind control study. There is no clinical study on the application of mifepristone to adenomyosis in foreign countries. Therefore, the clinical evidence is inadequate, and a high quality randomized controlled trial is still needed. The purpose of this study is to demonstrate the effectiveness and safety of mifepristone (10mg) in the treatment of symptomatic adenomyosis with multi center, random, double blind and controlled clinical trials. It is a new clinical study for the old medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | mifepristone tablets ,10mg,One tablet daily, oral treatment |
|
| control group | Placebo Comparator | placebo,10mg,One tablet daily, oral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in chronic pelvic pain associated with adenomyosis | To evaluate the visual analogue scale (VAS) changes.By using 10-cm visual analogue scales (0 = no pain, 10 = worst pain). Women will be asked to give the pain score at each follow up (i.e.Baseline ,taking medicine for 1-month, 2-month, 3-month, post treatment 1- month ) | Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month(approximately 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| changes in uterine bleeding | To evaluate the pictorial blood loss assessment chart (PBAC) changes | Baseline ,taking medicine for 1-month, 2-month, 3-month and post treatment 1- month(approximately 16 weeks) |
| improvement of anemia |
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Inclusion Criteria:
No menopause
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital of Zhejiang Medical University | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37307001 | Derived | Che X, Wang J, Sun W, He J, Wang Q, Zhu D, Zhu W, Zhang J, Dong J, Xu J, Zheng F, Zhou J, Zhao W, Lin Q, Ye L, Zhao X, Xu Z, Chen Y, Wang J, Wu W, Zhai L, Zhou Y, Zheng J, Zhang X. Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317860. doi: 10.1001/jamanetworkopen.2023.17860. |
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| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Jinhua Municipal Central Hospital |
| OTHER |
| The Central Hospital of Lishui City | OTHER |
| The Affiliated Hospital of Medical School of Ningbo University | UNKNOWN |
| Ningbo Maternity and Child Care Hospital | UNKNOWN |
| The People's Hospital of Quzhou | OTHER |
| Shaoxing Women and Children's Hospital | UNKNOWN |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Taizhou First People's Hospital | OTHER |
| Zhoushan Maternity and Infant Hospital | UNKNOWN |
| Shaoxing People's Hospital | OTHER |
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The appearance of Mifepristone Tablets and placebo tablets is the same (size, shape and color). In different treatment groups, the packaging of research drugs is the same, so that researchers or subjects or applicants can not know the assigned treatment.
| Placebo | Drug | Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating |
|
To evaluate the hemoglobin changes,
| Baseline ,taking medicine for 1-month, 3-month (approximately 16 weeks) |
| Size of uterus | To evaluate the uterine volume changes | Baseline ,taking medicine for 1-month, 3-month (approximately 16 weeks) |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |