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

53211036-02

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.

2022-06-13

2024-02-28

2026-02-28

Recruiting

Early phase I

172

Inclusion Criteria: 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. Exclusion Criteria: 1. 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) 2. 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. 3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication). 4. Those who require hysterectomy or other methods other than conservative treatment. 5. Known or suspected pregnancy. 6. Those who has contraindications to use progestin. 7. Deep vein thrombosis, stroke, myocardial infarction. 8. Severe joint lesions that prevent walking or movement. 9. untreated or recurrent pelvic inflammatory disease (PID) 10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine); 11. Cervical dysplasia 12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus 13. allergic to the LNG-IUS components 14. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All enrolled participants will receive enhanced lifestyle management to control weight and take LNG-IUS or Megestrol Acetate (MA) for treating EAH', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 172, 'type': 'ESTIMATED'}}

2023-05-31