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Progesterone Therapeutic Regimen Plus Statins 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
Started2023-04-01
Est. completion2025-08-01
Eligibility
Age17 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06102863
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
Age: 17 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * The pathological types are consistent with: 1. Atypical endometrial hyperplasia; 2. Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle infiltration, cervical involvement, and extrauterine metastasis; 3. There is a strong need to preserve reproductive function; Age ≤45 years old; 4. 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; 5. Informed consent and signed informed consent; 6. have follow-up conditions and are willing to continue to follow the visitors in the hospital; 7. Patients with normal/abnormal blood lipids who have not taken any lipid-lowering drugs; 8. 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 Criteria: * (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)
Conditions2
Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage ICancer
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Actively Recruiting
PhasePhase 2
SponsorPeking University People's Hospital
Started2023-04-01
Est. completion2025-08-01
Eligibility
Age17 Years – 45 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06102863