Overview

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)