Zagazig University
Zagazig, Sharqia Province, 44511, Egypt
NCT Number: NCT04385667
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.
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Interventional
Phase 2 / Phase 3
Zagazig, Sharqia Province, 44511, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy
Exclusion criteria
progestin delivery for regression of atypical endometrial hyperplasia
Other names: • Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.
progestin delivery for regression of atypical endometrial hyperplasia
Other names: • Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.
Time frame: 15 month
The success rate to accomplish complete regression of atypical endometrial hyperplasia
Time frame: 15 months
time till regression
Time frame: 8 months
incidence of partial regression and therapy failure
Time frame: 15 months
response rate in both premenopause and postmenopause women
Time frame: 15 months
incidence of thromboembolism with therapy
Time frame: 15 months
occurence of diabetes or hypertension ...ets
Zagazig University
Other Gov
The Efficacy of Levonorgestrel Intrauterine System Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia. A Randomized Controlled Trial.
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