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A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium

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Trial Profile

A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Apr 2023

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At a glance

  • Drugs Levonorgestrel (Primary) ; Metformin; Progesterone congeners
  • Indications Adenocarcinoma; Endometrial cancer; Endometrial hyperplasia
  • Focus Therapeutic Use
  • Acronyms feMMe
  • Most Recent Events

    • 13 Apr 2023 Planned End Date changed from 1 Dec 2021 to 1 Dec 2023.
    • 30 Mar 2021 Protocol was amended for reasons like; some patients were taking M already; others were ineligible for the WL intervention; and some young women who desired fertility did not meet the criteria because their BMI was lower than the required 30 kg/m2. So that patients who were ineligible for one of the three arms could still be enrolled.
    • 30 Mar 2021 Results published in the Gynecologic Oncology
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