Atypical Endometrial Hyperplasia
Conditions
Keywords
atypical endometrial hyperplasia, levonorgestrel intrauterine system, Megestrol acetate, partial regression
Brief 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.
Detailed 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
Interventions
DEVICElevonorgestrel intrauterine system (LNG-IUD)
progestin delivery for regression of atypical endometrial hyperplasia
DRUGOral Megesterol 160 mg daily
progestin delivery for regression of atypical endometrial hyperplasia
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate to accomplish complete regression of atypical endometrial hyperplasia | 15 month | The success rate to accomplish complete regression of atypical endometrial hyperplasia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| a- Duration needed to accomplish the complete recovery | 15 months | time till regression |
| b- The partial regression and failure rates. | 8 months | incidence of partial regression and therapy failure |
| c- Differential response rates between premenopausal and postmenopausal cases. | 15 months | response rate in both premenopause and postmenopause women |
| d- The risk of thromboembolic complications | 15 months | incidence of thromboembolism with therapy |
| f- Metabolic complications rates | 15 months | occurence of diabetes or hypertension ...ets |
Countries
Egypt
Outcome results
None listed