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

Last updated: April 25, 2025
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Endometrial Hyperplasia

Endometrial Cancer

Dysfunctional Uterine Bleeding

Treatment

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

Clinical Study ID

NCT06102863
20231022
  • Ages 17-45
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • The pathological types are consistent with:

  1. Atypical endometrial hyperplasia;

  2. Patients with highly differentiated endometrioid adenocarcinoma, stage IA, andpelvic 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. Progesterone resistant patients predicted by the progesterone sensitivityprediction model (NCT05647109) established by our team in the previous study ofendometrial cancer were prospectively randomized; The predicted progesteronesensitive 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 inthe hospital;

  7. Patients with normal/abnormal blood lipids who have not taken anylipid-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. Partialremission for 2 courses of treatment (24 weeks);

Exclusion

Exclusion Criteria:

  • (1) Patients with severe internal diseases and severe impairment of liver and kidneyfunction;

(2) Disease progression, extrauterine metastasis (cervical invasion or distantmetastasis 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 thereproductive system; Patients with breast cancer or other hormone-dependent tumorsthat cannot use progesterone;

(5) Patients with deep vein thrombosis, stroke and myocardial infarction duringtreatment;

(6) Alcoholics (> 20g/ day);

(7) Smokers (> 15 cigarettes/day)

Study Design

Total Participants: 38
Treatment Group(s): 1
Primary Treatment: statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Phase: 2
Study Start date:
April 01, 2023
Estimated Completion Date:
September 01, 2025

Study 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 detected by Raman scattering instrument. And Age, height, weight, waistline, blood pressure, basic history of infertility and family cancer will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 770.

Patients with endometrial cancer who met the inclusion criteria were randomly divided into the control group and the experimental group in a 1:1 ratio according to the random numbers generated in advance. The administration regimen for the two groups was as follows:

  1. Control group: progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or Mirena +GnRHa 3.75mg subcutaneous injection monthly);

  2. Trial group: 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);

The specific selection of progesterone regimen was based on whether the patients had oral progesterone contraindications and if BMI≥28kg/m2 was not suitable for oral progesterone, Mirena +GnRHa regimen was selected. The choice of statin drugs is based on the results of the drug sensitivity test of the patient's tumor tissue, and the most sensitive one of the three drugs is selected.

For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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