CompletedPhase 2/3

Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia

China36 participantsStarted 2020-09-01

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. Total cholesterol (TC) ≥ 5.2mmol/L (200mg/dL)
✓. Low-density lipoprotein cholesterol (LDL-C) ≥ 3.4mmol/L (130mg/dL)
✓. Fasting triglycerides (TG) ≥ 1.7mmol/L (150mg/dL)
✓. High-density lipoprotein cholesterol (HDL-C) \< 1.03mmol/L (40mg/dL)
✓. Apo-lipoprotein-A (Apo-A) \< 1.0g/L

What they're measuring

Pathological response rate

Timeframe: 12 to 16 weeks

Trial details

NCT IDNCT04491682

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-20

View on ClinicalTrials.gov More Atypical Endometrial Hyperplasia trials