RecruitingPhase 2NCT06102863

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


Sponsor

Peking University People's Hospital

Enrollment

38 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 17 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding statins (cholesterol-lowering drugs commonly used for heart disease) to standard progesterone hormone therapy can improve the chance of curing or controlling early-stage endometrial cancer (uterine cancer) or pre-cancerous uterine tissue in young women who want to preserve their ability to have children. **You may be eligible if...** - You are 45 years old or younger - You have been diagnosed with either atypical endometrial hyperplasia (pre-cancerous thickening of the uterine lining) or early-stage, well-differentiated endometrial cancer (Stage IA, confined to the uterus without deep invasion) - You strongly wish to preserve your fertility - You have not yet used progesterone treatment, or your cancer has not fully responded to progesterone treatment - Your liver and kidney function are adequate **You may NOT be eligible if...** - Your cancer has spread outside the uterus (cervix, pelvis, or distant metastases) - You have had prior cancer in the uterus or elsewhere that would complicate treatment - You have severe liver or kidney disease - You are allergic to the study medications or have contraindications to statins or progesterone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGstatins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);

Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa3.75mg subcutaneous injection monthly) combined with statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06102863