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To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin 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 will receive MPA (Medroxyprogesterone acetate) 250-500 mg by mouth daily plus atorvastatin 20mg by mouth daily for at least 3 months. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR. Patients with PD will be recommended for hysterectomy.
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. Three months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | MPA + Atorvastatin |
|
| Control groups | No Intervention | MPA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medroxyprogesterone acetate + Atorvastatin | Drug | MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological cumulative complete response rate; | 3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy, | assessed up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological cumulative complete response rate; | From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy, | assessed up to 8 months |
| The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WANG JIANLIU, PhD/MD | Contact | +861088324383 | wangjianliu1203@163.com | |
| HE YIJIAO, PhD | Contact | +8618301512017 | heyijiao2017@pku.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wang Jianliu | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;
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The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion |
| assessed up to 4 months |
| Overall complete response rate | Pathological response duration | up to 2 years |
| Pathological response rate classified by different blood lipid level | Pathological response rate classified by different blood lipid level | up to 2 years; |
| Relapse rate | Relapse rate | up to 15 months after the end of treatment |
| Pregnancy rate | Pregnancy rate | up to 15 months after the end of treatment |
| Toxic Side Effect | Toxicity evaluation according to CTCAE 5.0 version. | up to 3 months after the end of treatment |
| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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