Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

Fudan University36 enrolled

Overview

To see if megestrol acetate plus rosuvastatin will be superior to reversing the endometrial lesion to a normal endometrium than megestrol acetate alone in patients with atypical endometrial hyperplasia (AEH). Considering the large sample size in RCT, we used Simon two-stage design.

After diagnosed of AEH by hysteroscopy, patients will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels, anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 520. Patients are randomized to 1 of 2 treatment groups. Patients will receive MA 160 mg plus rosuvastatin 10mg by mouth daily for at least 6 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 simple or complex hyperplasia without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR or NR. Patients with PD will be recommended for hysterectomy. Two months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atypical Endometrial Hyperplasia

Interventions

Megestrol AcetateDRUG

At a dosage of 160 mg/day

RosuvastatinDRUG

At a dosage of 10 mg/day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a confirmed pathological diagnosis based upon hysteroscopy * Have a desire for remaining reproductive function or uterus * Good compliance with adjunctive treatment and follow-up * Abnormal blood lipid. At least meet one of the following five items: 1. Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL) 2. Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL) 3. Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL) 4. High-density lipoprotein cholesterol (HDL-C) \< 1.03mmol/L (40mg/dL) 5. Apo-lipoprotein-A (Apo-A) \< 1.0g/L Exclusion Criteria: * Acute liver disease or liver tumor (benign or malignant) or renal dysfunction * Pregnancy or potential pregnancy * Under treatment of high-dose progestin therapy more than 1 months in recent 6 months * Confirmed diagnosis of any cancer in reproductive system * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * Hypersensitivity or contradiction for using MA or statins * Already diagnosed with hyperlipidemia and using lipid-lowering drugs * 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)

Locations (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

Outcomes

Primary Outcomes

Pathological response rate

From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.

Time frame: 12 to 16 weeks

Secondary Outcomes

Pathological response rate

From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.

Time frame: 28 to 32 weeks

Pathological response duration

Time frame: Up to 2 years

Pathological response rate classified by different blood lipid level

Time frame: Up to 32 weeks

Toxicity evaluation

Toxicity evaluation according to CTCAE 5.0 version.

Time frame: Up to 32 weeks

Relapse rate

Time frame: up to 2 years after the therapy for each patient

Pregnancy rate

Time frame: up to 2 years after the therapy for each patient

Data from ClinicalTrials.gov

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