Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

NCT ID: NCT04491682

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-06-20

Brief Summary

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.

Detailed Description

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.

Conditions

Atypical Endometrial Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MA + Rosuvastatin

Patients will receive MA 160 mg and rosuvastatin 10 mg by mouth daily for at least 6 months.Then every 3 months, hysteroscopy will be used to evaluate the endometrial condition, and findings will be recorded.

Due to personal reasons, it may not be possible to accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.

Group Type: EXPERIMENTAL

Megestrol Acetate

Intervention Type: DRUG

At a dosage of 160 mg/day

Rosuvastatin

Intervention Type: DRUG

At a dosage of 10 mg/day

Interventions

Megestrol Acetate

At a dosage of 160 mg/day

Intervention Type: DRUG

Rosuvastatin

At a dosage of 10 mg/day

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Chen

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Chen

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology Hospital, Fudan University

Locations

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, , China

Countries

China

Other Identifiers

53211029-01

Identifier Type: -

Identifier Source: org_study_id