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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jianliu Wang, professor
• Email: wangjianliu1203@163.com
• Phone: 00861088324381

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Liquid biopsy screening for early endometrial cancer in regional China

  A non-invasive blood test using cell-free DNA is being tested to see if it can detect early endometrial cancer and tell apart benign from malignant uterine lesions.

  Recruiting Guizhou Provincial People's Hospital · Guiyang, Guizhou · NCT07892755

• Intrauterine type III collagen injection plus progestin for fertility-preserving endometrial cancer or atypical hyperplasia

  This test sees if adding an intrauterine injection of recombinant humanized type III collagen to high‑dose progestin helps women with early endometrial cancer or atypical hyperplasia preserve fertility and achieve tumor remission.

  Recruiting Phase 2 Peking University People's Hospital · Beijing · NCT07377734

• Using GnRHa and Letrozole for Obese Women with Progestin-Insensitive Endometrial Cancer

  This study is testing a new treatment combining GnRH antagonist and letrozole to see if it helps obese women with a specific type of endometrial cancer that hasn't responded to standard therapy.

  Recruiting at 2 sites Phase 2/3 Fudan University · Shanghai, Shanghai Municipality and 1 other locations · NCT06379113

• Predicting progesterone sensitivity in early endometrial cancer patients

  This study is testing a new way to predict how well early endometrial cancer patients will respond to progesterone treatments using their own tumor cells.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT05647109

• Combining GnRHa and Letrozole for Non-obese Patients with Endometrial Cancer

  This study is testing if a combination of GnRHa and letrozole can help non-obese patients with early-stage endometrial cancer keep their fertility when standard treatments haven't worked.

  Recruiting at 2 sites Phase 2/3 Fudan University · Shanghai, Shanghai Municipality and 1 other locations · NCT05316935

• Weight management combined with hormonal treatment for women with endometrial atypical hyperplasia

  This study is testing if combining weight management with hormonal treatments can help obese women with endometrial atypical hyperplasia who want to keep their fertility have better treatment results and pregnancy chances.

  Recruiting Phase 2/3 Fudan University · Shanghai · NCT05316493

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.