Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, China
Actively Recruiting
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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