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NCT05316493RecruitingPhase 2/3

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

Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
172 (estimated)
First submitted
23 Mar 2022
Start date
13 Jun 2022
Primary completion date
28 Feb 2026
Lead sponsor
Xiaojun Chen
Diseases
Obesity
NCT number
NCT05316493

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 172
  • From 13 Jun 2022 to the primary completion date, 28 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).

Other illness

  • Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.
  • Deep vein thrombosis, stroke, myocardial infarction.
  • untreated or recurrent pelvic inflammatory disease (PID)
  • an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
  • Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus
  • allergic to the LNG-IUS components
  • uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.
    • Notes: the last 6 criteria are only applied for patients with LNG-IUS.

Lab values

  • Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance < 30 mL/min)

Other

  • Those who require hysterectomy or other methods other than conservative treatment.
  • Known or suspected pregnancy.
  • Those who has contraindications to use progestin.
  • Severe joint lesions that prevent walking or movement.
  • Cervical dysplasia

Who the study is looking for

  • 1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
  • 5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
  • 6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Obstetrics and Gynecology Hospital of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.