Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Atorvastatin; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

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)