🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05316493
Recruiting Phase 2/3

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

NCT05316493 · tracked via the Priya Life Science China tracker
Sponsor
Xiaojun Chen
Phase
Phase 2/3
Started
2022-06-13
Last updated
2026-06-04

Condition(s) studied

Atypical Endometrial HyperplasiaFertility IssuesOverweight and Obesity

Investigational drug(s) / intervention(s)

Intensive Lifestyle Intervention (ILI)Megestrol Acetate 160 MG Oral TabletLevonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg

Intensive Lifestyle Intervention (ILI): dietary guidance, exercise guidance, lifestyle intervention

Megestrol Acetate 160 MG Oral Tablet: enrolled participants will take Megestrol Acetate 160mg daily

Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg: enrolled patients will be treated with LNG-IUS.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Obstetrics and Gynecology Hospital of Fudan University Shanghai China Recruiting

More Xiaojun Chen trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05316493 on ClinicalTrials.gov ↗ ← All trials in China