Atypical Endometrial Hyperplasia Clinical Trial
Official title:
Megestrol Acetate Plus LNG-IUS to Megestrol Acetate or LNG-IUS in Young Women With Endometrial Atypical Hyperplasia
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.
After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be
enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood
pressure, serum lipid level and side effects will be collected. Blood tests, including
fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG,
sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before
treatment to evacuate their metabolic conditions.
Patients are randomized to 1 of 3 treatment groups. Patients will receive MA (megestrol
acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive LNG-IUS
insertion on Arm II and MA 160 mg plus LNG-IUS insertion on Arm III. Then an hysteroscope
will be used to evaluate the endometrial condition every 3 months, and the findings will be
recorded. For patients with EAH, complete response (CR) is defined as the reversion of
endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response
(PR) is defined as regression to simple or complex hyperplasia without atypia; no response
(NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as
the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR,
NR or PD.
After completion of study treatment, 2 months of maintenance treatment will be recommended
for patients with CR, and participants will be followed up for 2 years.
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