Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 45Years
FEMALE
NCT05316493

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

Led by Xiaojun Chen · Updated on 2025-08-11

172

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 45 years
  • Body mass index (BMI) of 24 kg/m2 or higher
  • Signed informed consent
  • Pathologically confirmed diagnosis of endometrial atypical hyperplasia by biopsy, curettage, or hysteroscopy
  • Strong desire to preserve fertility or to keep the uterus despite no reproductive plans
  • Good compliance and willingness to follow up regularly at the Obstetrics and Gynecology Hospital of Fudan University
Not Eligible

You will not qualify if you...

  • Severe medical diseases or liver/kidney dysfunction (ALT or AST elevated 3 times above normal, creatinine clearance below 30 mL/min)
  • Diagnosis of other malignant reproductive tumors or breast/hormone-dependent cancers that contraindicate progesterone use
  • Use of high-dose progestin or oral contraceptives within the last 3 months
  • Need for hysterectomy or treatments other than conservative therapy
  • Known or suspected pregnancy
  • Contraindications to progestin
  • History of deep vein thrombosis, stroke, or myocardial infarction
  • Severe joint problems limiting movement
  • Untreated or recurrent pelvic inflammatory disease or pelvic infections
  • Cervical dysplasia
  • Uterine abnormalities including fibroids or shape issues
  • Allergy to LNG-IUS components
  • Uterine cavity size too large (over 7 cm diameter) or history of LNG-IUS expulsion (last six criteria apply only to LNG-IUS patients)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China

Actively Recruiting

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Research Team

W

WEIWEI SHAN, PhD

CONTACT

X

XIAOJUN CHEN, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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