Long-term Use of Mifepristone in the Treatment of Adenomyosis
NCT ID: NCT05151016
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
140 participants
INTERVENTIONAL
2021-12-01
2023-12-31
Brief Summary
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1. Study Group: mifepristone tablets, 10 mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks;
2. Control Group: dafinil (Triptorelin Acetate) , 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mifepristone
mifepristone tablets，10mg，One tablet daily, oral treatment
mifepristone
Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks
Triptorelin Acetate
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Triptorelin Acetate
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Interventions
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mifepristone
Mifepristone tablets, 10mg, 1 tablet daily, taken orally (beginning on the third day of Menstruation) for 24 weeks
Triptorelin Acetate
dafinil, 3.75 mg, first injection on the third day of menstruation, followed by intramuscular injection every 28 days for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* Patients were diagnosed as adenomyosis by postoperative pathology, or those who did not undergo surgery but were diagnosed by auxiliary examination, such as ultrasonography and MRI.
* Dysmenorrhea with or Without Menorrhagia
* Requiring preservation of the uterus or fertility
* No other hormonal treatment for Adenomyosis was received in the three months prior to treatment
* Normal or non-clinically significant cervical cytology results (6 months before the screening period)
Exclusion Criteria
* Benign Lesions such as endometrial polyp, submucous Myoma or suspicious malignant tumors were diagnosed by ultrasonography
* Receiving other hormone drugs for Adenomyosis
* Use other drugs that interact with tripriline acetate and mifepristone, and can not be stopped
* Patients with severe heart, liver, kidney disease and Adrenal insufficiency; drug allergy or allergic constitution
* Participated in other clinical trials within 3 months, and other factors considered unsuitable for the trial
* Pregnant, lactating women and those who prepare for childbirth during the treatment or within six months after treatment
* Postmenopausal women.
18 Years
50 Years
FEMALE
No
Sponsors
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Ningbo Women & Children's Hospital
OTHER
Jiaxing Maternity and Child Health Care Hospital
OTHER
The Affiliated Hospital of Medical School, Ningbo University
UNKNOWN
Qilu Hospital of Shandong University
OTHER
Obstetrics & Gynecology Hospital of Fudan University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Anhui Provincial Hospital
OTHER_GOV
Women's Hospital School Of Medicine Zhejiang University
OTHER
Responsible Party
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Locations
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Women's Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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20210229
Identifier Type: -
Identifier Source: org_study_id