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Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia

NCT05316493 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-08-11

No results posted yet for this study

Summary

To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy.

Conditions

  • Atypical Endometrial Hyperplasia
  • Fertility Issues
  • Overweight and Obesity

Interventions

BEHAVIORAL

Intensive Lifestyle Intervention (ILI)

dietary guidance, exercise guidance, lifestyle intervention

DRUG

Megestrol Acetate 160 MG Oral Tablet

enrolled participants will take Megestrol Acetate 160mg daily

DRUG

Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg

enrolled patients will be treated with LNG-IUS.

Sponsors & Collaborators

  • Xiaojun Chen

    lead OTHER

Principal Investigators

  • XIAOJUN CHEN, PhD · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2026-02-28
Completion
2027-02-28

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 NCT05316493 on ClinicalTrials.gov