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Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

NCT04491682 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-01-29

No results posted yet for this study

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

Interventions

DRUG

Megestrol Acetate

At a dosage of 160 mg/day

DRUG

Rosuvastatin

At a dosage of 10 mg/day

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xiaojun Chen · Obstetrics and Gynecology Hospital, Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-06-20
Completion
2022-06-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491682 on ClinicalTrials.gov