About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Medroxyprogesterone acetate + Atorvastatin
DrugMPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
Treatment groups
Trial outcomes
Primary outcomes
Pathological cumulative complete response rate;
3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,
Secondary outcomes
Pathological cumulative complete response rate;
From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy,
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion
Overall complete response rate
Pathological response duration
Pathological response rate classified by different blood lipid level
Pathological response rate classified by different blood lipid level
Sponsors and contacts
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