LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    140
  • sponsor
    Zagazig University
Updated on 7 July 2021
hysterectomy
progestin
levonorgestrel
megestrol acetate
atypical endometrial hyperplasia

Summary

This randomized controlled trial is aimed to compare the efficacy between Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD) regarding the ability and duration to produce complete regression for cases with atypical endometrial hyperplasia.

Description

Up to 25% of cases with endometrial cancer and atypical hyperplasia occur in premenopausal women. The progressively increasing trend of delay in first conception increases such patients who wish to have children.3 The recommended treatment for EH without atypia is primarily hormonal, whereas the preferred treatment for EH with atypia is hysterectomy given the significant risk for both concurrent and subsequent development of endometrial carcinoma. A dilemma results when EH with atypia is diagnosed in women who wish to retain fertility or declining doing hysterectomy due to concomitant medical morbidities. In these women, a trial of hormone therapy can be considered.4,5 In recent years, progestin therapy has been successfully used to treat selected women with endometrial cancer and atypical hyperplasia who desire to preserve fertility or having severe medical co-morbidities precluding (immediate) surgery. The most common progestin regimens include Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD).5-7

Details
Condition Disorder of uterus NOS, Endometrial Hyperplasia, Uterine Disorders, atypical endometrial hyperplasia
Treatment levonorgestrel intrauterine system (LNG-IUD), Oral Megesterol 160 mg daily
Clinical Study IdentifierNCT04385667
SponsorZagazig University
Last Modified on7 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All cases with evidence of atypical endometrial hyperplasia declining doing
hysterectomy

Exclusion Criteria

Cases with evidence of associated endometrial cancer
Cases with simple hyperplasia without atypia
Patients failed to collect at least 2 endometrial samples during treatment course
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