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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
At a dosage of 160 mg/day
Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Pathological response rate
the proportion of histologic regression from endometrial atypical hyperplasia to benign endometrium
Time frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
Pathological response time
time of histologic regression from endometrial atypical hyperplasia to benign endometrium
Time frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Common side effects from these drugs include weight gain, vaginal spotting and descent of sexuality. Severe side effects include thrombus and diseases related. The investigators will record any mental or body symptoms and evaluate the correlation.
Time frame: up to 2 years after the treatment for each patient
Rate of relapse
the proportion of experiencing recurrence after regression
Time frame: up to 2 years after the treatment for each patient
Rate of pregnancy
the proportion of getting pregnancy after regression
Time frame: up to 2 years after the treatment for each patient
Compliance
The investigators designed a questionnaire to evaluate the compliance through treatment as side effects of oral megestrol acetate may be more common than LNG-IUS. Self Efficacy, physical activity and social support will be scored (1 to 5) and compared among each arm.
Time frame: up to 2 years after the treatment for each patient
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