Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia
Recruiting now · Phase 2
Conditions studied: Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I
In brief
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.
Key facts
- Study ID
- NCT06102863
- Run by
- Peking University People's Hospital
- People needed
- 38
- Starts
- 2023-04-01
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-04-29
Who can join
Age: 17 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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);
You may not qualify if…
- (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)
Where it is running
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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