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Recruiting
NCT05675787
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Conditions: Atypical Endometrial Hyperplasia, Endometrial Carcinoma Stage I
Sex: Female
Ages: 17 Years – 45 Years
Phase: PHASE2
Enrollment: 82
Sponsor: Peking University People's Hospital
Location: China
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 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 ultrasoundHave a desire for remaining reproductive function or uterusGood compliance with adjunctive treatment and follow-upExclusion Criteria:Hypersensitivity or contradiction for using MPA or atorvastatinPregnancy or potential pregnancyConfirmed diagnosis of any cancer in reproductive systemAlready diagnosed with hyperlipidemia and using lipid-lowering drugsAcute liver disease or liver tumor (benign or malignant) or renal dysfunctionAcute severe disease such as stroke or heart infarction or a history of thrombosis diseaseWith other factors of reproductive dysfunction;Strong request for uterine removal or other conservative treatmentSmoker (>15 cigarettes a day)Drinker (>20 grams a day)
Source: ClinicalTrials.gov (NCT05675787). StuddyBuddy aggregates publicly available trial information.