Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia

• Status: Completed
• Trial end date: 2020-06-18
• Target enrollment: 0
• Participant gender: Female

Summary

To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate or LNG-IUS alone in patients with endometrial atypical hyperplasia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Shanghai 6th People's Hospital; Shanghai Changning Maternity & Infant Health Hospital; Zhejiang Cancer Hospital
• Treatments: Levonorgestrel; Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon hysteroscopy

• Have a desire for remaining reproductive function or uterus

• Need to be able to undergo correlative treatment and follow-up

Exclusion Criteria:

• Acute liver disease or liver tumor (benign or malignant) or renal dysfunction

• Pregnancy or suspicion of pregnancy

• Have a history of EAH and have disease relapse during Merina insertion

• Under treatment of high-dose progestin therapy more than 3 months in recent 6 months

• Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity

• Confirmed diagnosis of malignant tumor in genital system

• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease

• Hypersensitivity or contradiction to any component of this product

• Ask for removal of the uterus or other conservative treatment

• Smoker(>15 cigarettes a day)