Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

NCT04491682 | Completed Phase 2

• 1 other identifier: 53211029-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Atypical Endometrial Hyperplasia

Keywords

megestrol acetate; rosuvastatin; atypical endometrial hyperplasia; conservative treatment

Outcome Measures

Primary Outcomes (1)

• 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 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 therapy for each patient

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, it may not be possible to 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
• 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 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)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Endometrial Hyperplasia

Interventions

Megestrol Acetate; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

  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

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 29, 2020
• Study Start: September 1, 2020
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CN (1)