๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค45 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)
๐
What it tests
- statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Peking University People's Hospital
Beijing, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.