Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia

  • STATUS
    Recruiting
  • End date
    Feb 28, 2027
  • participants needed
    192
  • sponsor
    Fudan University
Updated on 20 February 2021

Summary

To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

Description

Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.

Details
Condition Disorder of uterus NOS, Endometrial Hyperplasia, Uterine Disorders, atypical endometrial hyperplasia
Treatment Megestrol Acetate, Metformin plus Megestrol acetate
Clinical Study IdentifierNCT04607252
SponsorFudan University
Last Modified on20 February 2021

Eligibility

Yes No Not Sure

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

Patients who had one or more of the following conditions
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)
high risk of thrombosis
recurrent AEH
endometrial cancer
other malignancy history
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