Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

Atypical Endometrial Hyperplasia Clinical Trial

Official title:

Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491682
• Other study ID #: 53211029-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Endometrial Hyperplasia
• Hyperplasia

Intervention

Drug:
• Megestrol Acetate
At a dosage of 160 mg/day
• Rosuvastatin
At a dosage of 10 mg/day

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 to 16 weeks
Secondary	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.	28 to 32 weeks
Secondary	Pathological response duration	Pathological response duration	Up to 2 years
Secondary	Pathological response rate classified by different blood lipid level	Pathological response rate classified by different blood lipid level	Up to 32 weeks
Secondary	Toxicity evaluation	Toxicity evaluation according to CTCAE 5.0 version.	Up to 32 weeks
Secondary	Relapse rate		up to 2 years after the therapy for each patient
Secondary	Pregnancy rate		up to 2 years after the therapy for each patient