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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05675787

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atypical Endometrial Hyperplasia Endometrial Carcinoma Stage I	Drug: Medroxyprogesterone acetate + Atorvastatin	Phase 2

Detailed Description

After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;Participants are assigned to one of two groups in parallel for the duration of the study: Control group and Experimental group;

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group MPA + Atorvastatin	Drug: Medroxyprogesterone acetate + Atorvastatin MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,
No Intervention: Control groups MPA

Arm

Intervention/Treatment

Experimental: Experimental group

MPA + Atorvastatin

Drug: Medroxyprogesterone acetate + Atorvastatin

MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,

No Intervention: Control groups

MPA

Outcome Measures

Primary Outcome Measures

Pathological cumulative complete response rate; [assessed up to 4 months]
3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,

Secondary Outcome Measures

Pathological cumulative complete response rate; [assessed up to 8 months]
From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy,
Overall complete response rate [up to 2 years]
Pathological response duration
Pathological response rate classified by different blood lipid level [up to 2 years;]
Pathological response rate classified by different blood lipid level
Relapse rate [up to 15 months after the end of treatment]
Relapse rate
Pregnancy rate [up to 15 months after the end of treatment]
Pregnancy rate
Toxic Side Effect [up to 3 months after the end of treatment]
Toxicity evaluation according to CTCAE 5.0 version.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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;

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)