Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma

NCT04491643 | Completed Phase 2

• 1 other identifier: 53211029-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Carcinoma Stage I

Keywords

megestrol acetate; rosuvastatin; endometrial carcinoma stage I limited to endometrium; conservative treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pathological response rate

  28 to 32 weeks

• Pathological response duration

  up to 2 years

• Pathological response rate classified by different blood lipid level

  up to 32 weeks

• Toxicity evaluation

  up to 32 weeks

• Relapse rate

  Up to 2 years after the end of treatment

Study Arms (1)

MA + Rosuvastatin

EXPERIMENTAL

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; Drug: Rosuvastatin

Interventions

Megestrol Acetate DRUG

At a dosage of 160 mg/day

MA + Rosuvastatin

Rosuvastatin DRUG

At a dosage of 10 mg/day

MA + Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
• Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)
• Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)
• High-density lipoprotein cholesterol (HDL-C) \< 1.03mmol/L (40mg/dL)
• Apo-lipoprotein-A (Apo-A) \< 1.0g/L

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Megestrol Acetate; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaojun Chen, PhD

  Obstetrics and Gynecology Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Simon two-stage optimal design

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 29, 2020
• Study Start: September 1, 2020
• Primary Completion: August 11, 2023
• Study Completion: April 11, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)