|

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

RECRUITINGPhase 2Sponsored by Peking University People's Hospital
Actively Recruiting
PhasePhase 2
SponsorPeking University People's Hospital
Started2023-04-01
Est. completion2025-08-01
Eligibility
Age17 Years – 45 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 17 Years – 45 YearsSex: FEMALEHealthy volunteers accepted
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 ≤45 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)

Conditions2

Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage ICancer

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.