Status:
RECRUITING
Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beihang University
Peking University
Conditions:
Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I
Eligibility:
FEMALE
17-45 years
Phase:
PHASE2
Brief 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 treatm...
Detailed Description
After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue was detec...
Eligibility Criteria
Inclusion
- 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
- (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)
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06102863
Start Date
April 1 2023
End Date
September 1 2025
Last Update
April 29 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044