Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Atorvastatin; Calcium; Rosuvastatin Calcium

Criteria

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. The content of cholesterol esters in endometrial cancer PTCs was detected by Raman scattering technique to exceed 35%;

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)