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NCT06102863RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
38 (estimated)
First submitted
22 Oct 2023
Start date
1 Apr 2023
Primary completion date
1 Aug 2025
Lead sponsor
Peking University People's Hospital
NCT number
NCT06102863

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 38
  • From 1 Apr 2023 to the primary completion date, 1 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • (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)

Who the study is looking for

  • 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);

Age in the registry: 17 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.