A Phase 2 interventional study of statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day); in Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to female participants aged 17 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
Among 22 studies in Endometrial Hyperplasia with a site in China — 14 open to participants now, 15 under way, 5 of them phase 3. Endometrial Hyperplasia · China.
Among the 22 studies in Endometrial Hyperplasia with a site in China, this one is the 12th largest by planned enrollment of the 19 interventional ones, is one of 3 that started in 2023, is one of 7 in phase 2, reaches primary completion later than 2 of the 14 other live ones, and was the 12th registered.
110 studies on the registry are indexed under Endometrial Hyperplasia; 38 are open to participants now.
This study's planned enrollment of 38 is below the median of 80 across 71 interventional studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →14 of the 22 studies in Endometrial Hyperplasia with a site in China are open now, in 1 country. Each count lists the studies.
Of the 21 Endometrial Hyperplasia studies recruiting now, 9 (43%) set no upper age limit and 11 (52%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 17 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2023.
Median enrollment 75 across the 19 interventional studies, 512 across the 3 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
1 of 22 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Peking University People's Hospital has 5 studies filed under Endometrial Hyperplasia — fewer than ten, so there is no comparison to draw.
2 of the studies in Endometrial Hyperplasia with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07892755Guizhou Provincial People's HospitalLiquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations | 2027-08-09 |
| NCT07714070Peking University People's HospitalOrlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia | 2027-09 |
Among the 22 studies in Endometrial Hyperplasia with a site in China, from their registry updates:
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The pathological types are consistent with:
Exclusion Criteria:
(1) Patients with severe internal diseases and severe impairment of liver and kidney function;
(2) Disease progression, extrauterine (cervical invasion or distant metastasis such as pelvic cavity) during treatment;
(3) People with therapeutic drug allergies and ;
(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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Progesterone regimen (oral medroxyprogesterone acetate tablet 250mg-500mg/ day or mirena +GnRHa 3.75mg subcutaneous injection monthly);
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);
Drug: statins (oral atorvastatin calcium tablet 20mg/ day; Or rosuvastatin 5mg/ day; Or pivastatin 2mg/ day);
Drug page: Atorvastatin
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);
Pathological cumulative complete response rate;
From 6 to 7 months: From date of initial therapy until the date of CR.
Time frame: assessed up to 7 months
Pathological cumulative complete response rate;
From 3 to 4 months; From date of initial therapy until the date of CR.
Time frame: assessed up to 4 months
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue
The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion
Time frame: assessed up to 7 months
Overall complete response rate
Pathological response duration
Time frame: up to 2 years
Relapse rate
Relapse rate
Time frame: up to 15 months after the end of treatment.
Toxic Side Effect
Toxicity evaluation according to CTCAE 5.0 version.
Time frame: up to 3 months after the end of treatment.
Pregnancy rate
Number of pregnancies after complete remission.
Time frame: up to 15 months after the end of treatment.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Aug 2025, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Atorvastatin
Peking University People's Hospital →