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
1 other identifier
interventional
172
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedAugust 11, 2025
August 1, 2025
3.7 years
March 23, 2022
August 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological complete response (CR) rates
The 28-week CR rates will be calculated in four arms
From date of recruitment until the date of CR, assessed up to 28 weeks.
Secondary Outcomes (18)
Pregnancy outcomes
up to 2 years after complete response of the last participant
Weight change
From date of recruitment, assessed up to 28 weeks.
Body composition change
From date of recruitment, assessed up to 28 weeks.
Blood pressures change
From date of recruitment, assessed up to 28 weeks.
Heart rates change
From date of recruitment, assessed up to 28 weeks.
- +13 more secondary outcomes
Study Arms (4)
overweight MA+ILI
EXPERIMENTALenrolled overweight (24kg/m2≤BMI\<28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management
overweight LNG-IUS+ILI
EXPERIMENTALenrolled overweight (24kg/m2≤BMI\<28kg/m2) patients will be treated with LNG-IUS plus weight management
obese MA+ILI
EXPERIMENTALenrolled obese (BMI≥28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management
obese LNG-IUS+ILI
EXPERIMENTALenrolled obese (BMI≥28kg/m2) patients will be treated with LNG-IUS plus weight management
Interventions
dietary guidance, exercise guidance, lifestyle intervention
enrolled participants will take Megestrol Acetate 160mg daily
enrolled patients will be treated with LNG-IUS.
Eligibility Criteria
You may qualify if:
- 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.
- Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
- Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.
You may not qualify if:
- 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)
- 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.
- Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
- Those who require hysterectomy or other methods other than conservative treatment.
- Known or suspected pregnancy.
- Those who has contraindications to use progestin.
- Deep vein thrombosis, stroke, myocardial infarction.
- Severe joint lesions that prevent walking or movement.
- untreated or recurrent pelvic inflammatory disease (PID)
- an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
- Cervical dysplasia
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaojun Chenlead
Study Sites (1)
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
XIAOJUN CHEN, PhD
Obstetrics & Gynecology Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 7, 2022
Study Start
June 13, 2022
Primary Completion
February 28, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share