CompletedPhase 2/3

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

China180 participantsStarted 2017-07-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Pathological response rate

Timeframe: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Pathological response time

Timeframe: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Trial details

NCT IDNCT03241888

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-18

View on ClinicalTrials.gov More Atypical Endometrial Hyperplasia trials

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pathological response rate

Timeframe: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Pathological response time

Timeframe: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months