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

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Dec 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two medications, medroxyprogesterone acetate and atorvastatin, to see how well they work in treating young women with two specific conditions: atypical endometrial hyperplasia (a growth in the lining of the uterus that can lead to cancer) and early-stage endometrial carcinoma (a type of cancer in the uterus). The goal is to find a safe and effective treatment that allows women to keep their uterus and maintain their ability to have children, if they wish.

To be eligible for this trial, participants need to be women diagnosed with either atypical endometrial hyperplasia or early endometrial carcinoma that hasn’t spread beyond the uterus. They should not have had prior treatment that completely cleared their condition, and they need to show a desire to keep their uterus. Participants will be closely monitored during the study and will receive regular follow-ups. This trial is currently recruiting women between the ages of 18 and 45, and it's important to note that some health conditions, such as severe liver or kidney disease, or current pregnancy, would make someone ineligible to participate.

Gender

FEMALE

Eligibility 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)