RecruitingPhase 2NCT06102863
Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Sponsor
Peking University People's Hospital
Enrollment
38 participants
Start Date
Apr 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Statins 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 Criteria9
- The pathological types are consistent with:
- Atypical endometrial hyperplasia;
- Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle infiltration, cervical involvement, and extrauterine metastasis;
- There is a strong need to preserve reproductive function; Age ≤45 years old;
- Progesterone resistant patients predicted by the progesterone sensitivity prediction model (NCT05647109) established by our team in the previous study of endometrial cancer were prospectively randomized; The predicted progesterone sensitive patients were prospectively observed;
- Informed consent and signed informed consent;
- have follow-up conditions and are willing to continue to follow the visitors in the hospital;
- Patients with normal/abnormal blood lipids who have not taken any lipid-lowering drugs;
- A. Newly treated patients: did not use any nursery therapy drugs (progesterone, GNRH-a); B. 1 course of treatment (12 weeks) the lesions persisted; C. Partial remission for 2 courses of treatment (24 weeks);
Exclusion Criteria7
- (1) Patients with severe internal diseases and severe impairment of liver and kidney function;
- (2) Disease progression, extrauterine metastasis (cervical invasion or distant metastasis such as pelvic cavity) during treatment;
- (3) People with therapeutic drug allergies and contraindications;
- (4) Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; Patients with breast cancer or other hormone-dependent tumors that cannot use progesterone;
- (5) Patients with deep vein thrombosis, stroke and myocardial infarction during treatment;
- (6) Alcoholics (\> 20g/ day);
- (7) Smokers (\> 15 cigarettes/day)
Interventions
DRUGstatins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06102863