Combining progesterone and statins for young women with early endometrial cancer and atypical hyperplasia

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

This study is testing whether combining progesterone with statins can help young women with early endometrial cancer and atypical hyperplasia while preserving their ability to have children.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 17 Years to 45 Years
• Sex: Female
• Sponsor: Peking University People's Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06102863 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a treatment regimen combining progesterone and statins for young women diagnosed with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC). Patients will be randomly assigned to either a control group receiving only progesterone or an experimental group receiving both progesterone and statins. The study will assess various health metrics, including lipid levels and hormonal profiles, to evaluate the treatment's impact on the endometrial lesions. The goal is to provide a conservative treatment option that preserves reproductive function in eligible patients.

Who should consider this trial

Good fit: Ideal candidates are women aged 45 or younger with atypical endometrial hyperplasia or early-stage endometrial carcinoma who wish to preserve their reproductive function.

Not a fit: Patients with advanced endometrial cancer or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new conservative option for young women with early-stage endometrial cancer, potentially preserving their reproductive capabilities.

How similar studies have performed: While the combination of progesterone and statins is a novel approach, previous studies have shown promise in using progesterone for similar conditions, indicating potential for success.

Eligibility criteria

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)

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jianliu Wang, professor

Conditions: Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I