Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: Female

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 hyperplasia (AEH). Considering the large sample size in RCT, we used Simon two-stage design.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Megestrol; Megestrol Acetate; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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:

1. Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)

2. Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)

3. Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)

4. High-density lipoprotein cholesterol (HDL-C) <1.03mmol/L (40mg/dL)

5. Apo-lipoprotein-A (Apo-A) ≥ 1.0g/L

Exclusion Criteria:

• 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)