Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endom… (NCT04607252) | Clinical Trial Compass
TerminatedPhase 2/3
Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
Stopped: Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.
China12 participantsStarted 2021-01-11
Plain-language summary
To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 18-45 years old;
✓. pathologically diagnosed with AEH for the first time;
✓. desire to preserve their fertility;
✓. no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
✓. no contraindication for metformin, megestrol acetate or pregnancy;
✓. no hormone or metformin treatment within 6 months before entering the trial;
✓. not pregnant when participating in the trial;
✓. willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.
Exclusion criteria
✕. allergy history or contraindications for megestrol acetate or metformin;
✕. pregnant when initiating the study;
✕. alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);