Status:
COMPLETED
Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia
Lead Sponsor:
Fudan University
Conditions:
Atypical Endometrial Hyperplasia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
To see if megestrol acetate plus rosuvastatin will be superior to reversing the endometrial lesion to a normal endometrium than megestrol acetate alone in patients with atypical endometrial hyperplasi...
Detailed Description
After diagnosed of AEH by hysteroscopy, patients will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure will be collected. Blood te...
Eligibility Criteria
Inclusion
- Have a confirmed pathological diagnosis based upon hysteroscopy
- Have a desire for remaining reproductive function or uterus
- Good compliance with adjunctive treatment and follow-up
- Abnormal blood lipid. At least meet one of the following five items:
- Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
- Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)
- Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)
- High-density lipoprotein cholesterol (HDL-C) \< 1.03mmol/L (40mg/dL)
- Apo-lipoprotein-A (Apo-A) \< 1.0g/L
Exclusion
- Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
- Pregnancy or potential pregnancy
- Under treatment of high-dose progestin therapy more than 1 months in recent 6 months
- Confirmed diagnosis of any cancer in reproductive system
- Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
- Hypersensitivity or contradiction for using MA or statins
- Already diagnosed with hyperlipidemia and using lipid-lowering drugs
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04491682
Start Date
September 1 2020
End Date
June 20 2022
Last Update
January 29 2024
Active Locations (1)
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1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, China