Obstetrics and Gynecology Hospital, Fudan University
Shanghai, China
NCT Number: NCT04491682
To see if megestrol acetate plus rosuvastatin will be superior to reversing the endometrial lesion to a normal endometrium than megestrol acetate alone in patients with atypical endometrial hyperplasia (AEH). Considering the large sample size in RCT, we used Simon two-stage design.
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Notify Me18 year–45 year
Female
Interventional
Phase 2 / Phase 3
Shanghai, China
After diagnosed of AEH by hysteroscopy, patients will be enrolled. Age, height, weight, waist circumstances, blood pressure, basic history of infertility and blood pressure will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), OGTT 2h blood glucose and insulin, blood lipids, SHBG, sex hormone levels, anti-müllerian hormone(AMH), creatine kinase(CK) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 520.
Patients are randomized to 1 of 2 treatment groups. Patients will receive MA 160 mg plus rosuvastatin 10mg by mouth daily for at least 6 months. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. 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 atypic; stable disease (SD) 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 or NR. Patients with PD will be recommended for hysterectomy.
Two months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At a dosage of 160 mg/day
At a dosage of 10 mg/day
Time frame: 12 to 16 weeks
From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 16 weeks.
Time frame: 28 to 32 weeks
From date of randomization or initial therapy until the date of CR or date of hysterectomy, whichever come first, assessed up to 32 weeks.
Time frame: Up to 2 years
Pathological response duration
Time frame: Up to 32 weeks
Pathological response rate classified by different blood lipid level
Time frame: Up to 32 weeks
Toxicity evaluation according to CTCAE 5.0 version.
Time frame: up to 2 years after the therapy for each patient
Time frame: up to 2 years after the therapy for each patient
Fudan University
Other
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