Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma

To explore the treatment efficacy of megestrol acetate plus rosuvastatin in patients with early endometrial carcinoma (EEC) seeking for conservative treatment.

Study Overview

• Status: Completed
• Conditions: Endometrial Carcinoma Stage I
• Intervention / Treatment: Drug: Megestrol Acetate; Drug: Rosuvastatin

Detailed Description

After diagnosed of EEC by hysteroscopy, patients meet the study criteria 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 will receive MA (megestrol acetate) 160 mg by mouth daily 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 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 or NR. Patients with PD will be recommended for hysterectomy.

Due to personal reasons, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months. For patients remained SD after 6 to 8 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given.

Two months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Obstetrics and Gynecology Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
• 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

• 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 atorvastatin
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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, patients may not accept hysteroscopic evaluation every three months, then the longest duration will be 8 months.	Drug: Megestrol Acetate; At a dosage of 160 mg/day; Drug: Rosuvastatin; At a dosage of 10 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response rate	From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.	12 to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological response rate	From date of initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.	28 to 32 weeks
Pathological response duration	Pathological response duration	up to 2 years
Pathological response rate classified by different blood lipid level	Pathological response rate classified by different blood lipid level	up to 32 weeks
Toxicity evaluation	Toxicity evaluation according to CTCAE 5.0 version.	up to 32 weeks
Relapse rate		Up to 2 years after the end of treatment
Pregnancy rate		Up to 2 years after the end of treatment

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Xiaojun Chen, PhD, Obstetrics and Gynecology Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): April 11, 2025

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: rosuvastatin; conservative treatment; megestrol acetate; endometrial carcinoma stage I limited to endometrium
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Uterine Neoplasms; Carcinoma; Endometrial Neoplasms; Contraceptive Agents, Hormonal; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Reproductive Control Agents; Antimetabolites; Central Nervous System Stimulants; Contraceptive Agents, Female; Contraceptive Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Contraceptives, Oral; Contraceptives, Oral, Hormonal; Contraceptives, Oral, Synthetic; Appetite Stimulants; Rosuvastatin Calcium; Megestrol; Megestrol Acetate
• Other Study ID Numbers: 53211029-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No