Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

Peking University

Status and phase

Enrolling

Phase 2

Conditions

Endometrial Carcinoma Stage I

Atypical Endometrial Hyperplasia

Treatments

Drug: Medroxyprogesterone acetate + Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT05675787

2022PHB416

Details and patient eligibility

About

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.

Full description

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.

Enrollment

82 estimated patients

Sex

Female

Ages

17 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;
No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
Have a desire for remaining reproductive function or uterus
Good compliance with adjunctive treatment and follow-up

Exclusion criteria

Hypersensitivity or contradiction for using MPA or atorvastatin
Pregnancy or potential pregnancy
Confirmed diagnosis of any cancer in reproductive system
Already diagnosed with hyperlipidemia and using lipid-lowering drugs
Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
With other factors of reproductive dysfunction;
Strong request for uterine removal or other conservative treatment
Smoker (>15 cigarettes a day)
Drinker (>20 grams a day)