Status:
COMPLETED
Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Endometrial Carcinoma Stage I
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
To explore the treatment efficacy of megestrol acetate plus rosuvastatin in patients with early endometrial carcinoma (EEC) seeking for conservative treatment.
Detailed Description
After diagnosed of EEC by hysteroscopy, patients meet the study criteria will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure wil...
Eligibility Criteria
Inclusion
- Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
- 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
- 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 atorvastatin
- 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 :
April 11 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04491643
Start Date
September 1 2020
End Date
April 11 2025
Last Update
August 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, China