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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
143
progestin delivery for regression of atypical endometrial hyperplasia
progestin delivery for regression of atypical endometrial hyperplasia
Zagazig University
Zagazig, Sharqia Province, Egypt
The success rate to accomplish complete regression of atypical endometrial hyperplasia
The success rate to accomplish complete regression of atypical endometrial hyperplasia
Time frame: 15 month
a- Duration needed to accomplish the complete recovery
time till regression
Time frame: 15 months
b- The partial regression and failure rates.
incidence of partial regression and therapy failure
Time frame: 8 months
c- Differential response rates between premenopausal and postmenopausal cases.
response rate in both premenopause and postmenopause women
Time frame: 15 months
d- The risk of thromboembolic complications
incidence of thromboembolism with therapy
Time frame: 15 months
f- Metabolic complications rates
occurence of diabetes or hypertension ...ets
Time frame: 15 months
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