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Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
RECRUITINGPhase 2Sponsored by Peking University People's Hospital
Actively Recruiting
PhasePhase 2
SponsorPeking University People's Hospital
Started2023-01-06
Est. completion2025-08-31
Eligibility
Age17 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05675787
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
Age: 17 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
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)
Conditions3
Atypical Endometrial HyperplasiaCancerEndometrial Carcinoma Stage I
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Actively Recruiting
PhasePhase 2
SponsorPeking University People's Hospital
Started2023-01-06
Est. completion2025-08-31
Eligibility
Age17 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05675787