Atypical Endometrial Hyperplasia Clinical Trial
Official title:
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.
Status | Recruiting |
Enrollment | 82 |
Est. completion date | October 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 17 Years to 45 Years |
Eligibility | Inclusion Criteria: - Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy; - No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound - Have a desire for remaining reproductive function or uterus - Good compliance with adjunctive treatment and follow-up Exclusion Criteria: - Hypersensitivity or contradiction for using MPA or atorvastatin - Pregnancy or potential pregnancy - Confirmed diagnosis of any cancer in reproductive system - Already diagnosed with hyperlipidemia and using lipid-lowering drugs - Acute liver disease or liver tumor (benign or malignant) or renal dysfunction - Acute severe disease such as stroke or heart infarction or a history of thrombosis disease - With other factors of reproductive dysfunction; - Strong request for uterine removal or other conservative treatment - Smoker (>15 cigarettes a day) - Drinker (>20 grams a day) |
Country | Name | City | State |
---|---|---|---|
China | Wang Jianliu | Peking | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathological cumulative complete response rate; | 3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy, | assessed up to 4 months | |
Secondary | Pathological cumulative complete response rate; | From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy, | assessed up to 8 months | |
Secondary | The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue | The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion | assessed up to 4 months | |
Secondary | Overall complete response rate | Pathological response duration | up to 2 years | |
Secondary | Pathological response rate classified by different blood lipid level | Pathological response rate classified by different blood lipid level | up to 2 years; | |
Secondary | Relapse rate | Relapse rate | up to 15 months after the end of treatment | |
Secondary | Pregnancy rate | Pregnancy rate | up to 15 months after the end of treatment | |
Secondary | Toxic Side Effect | Toxicity evaluation according to CTCAE 5.0 version. | up to 3 months after the end of treatment |
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