RecruitingPhase 2NCT05675787
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
Sponsor
Peking University People's Hospital
Enrollment
82 participants
Start Date
Jan 6, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 17 YearsMax Age: 45 Years
Inclusion Criteria4
- 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 Criteria10
- 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)
Interventions
DRUGMedroxyprogesterone acetate + Atorvastatin
MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05675787
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