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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levonorgestrel intrauterine system (LNG-IUD) | Active Comparator | levonorgestrel intrauterine system (LNG-IUD) applied.
|
|
| Megestrol acetate (MA) | Active Comparator | Megesterol arm will receive 160 mg daily
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel intrauterine system (LNG-IUD) | Device | progestin delivery for regression of atypical endometrial hyperplasia |
|
| Measure | Description | Time Frame |
|---|---|---|
| The success rate to accomplish complete regression of atypical endometrial hyperplasia | The success rate to accomplish complete regression of atypical endometrial hyperplasia | 15 month |
| Measure | Description | Time Frame |
|---|---|---|
| a- Duration needed to accomplish the complete recovery | time till regression | 15 months |
| b- The partial regression and failure rates. | incidence of partial regression and therapy failure |
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Inclusion Criteria:
All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amr Alnemr, M.D. | Faculty of Medicine- Zagazig university | Principal Investigator |
| Hytham Atia, M.D. | Faculty of Medicine- Zagazig university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Zagazig | Sharqia Province | 44511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22863972 | Background | Armstrong AJ, Hurd WW, Elguero S, Barker NM, Zanotti KM. Diagnosis and management of endometrial hyperplasia. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):562-71. doi: 10.1016/j.jmig.2012.05.009. Epub 2012 Aug 3. | |
| 20613899 | Background | Salman MC, Usubutun A, Boynukalin K, Yuce K. Comparison of WHO and endometrial intraepithelial neoplasia classifications in predicting the presence of coexistent malignancy in endometrial hyperplasia. J Gynecol Oncol. 2010 Jun;21(2):97-101. doi: 10.3802/jgo.2010.21.2.97. Epub 2010 Jun 30. |
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| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Oral Megesterol 160 mg daily | Drug | progestin delivery for regression of atypical endometrial hyperplasia |
|
|
| 8 months |
| c- Differential response rates between premenopausal and postmenopausal cases. | response rate in both premenopause and postmenopause women | 15 months |
| d- The risk of thromboembolic complications | incidence of thromboembolism with therapy | 15 months |
| f- Metabolic complications rates | occurence of diabetes or hypertension ...ets | 15 months |
| 26428941 | Background | Zhou R, Yang Y, Lu Q, Wang J, Miao Y, Wang S, Wang Z, Zhao C, Wei L. Prognostic factors of oncological and reproductive outcomes in fertility-sparing treatment of complex atypical hyperplasia and low-grade endometrial cancer using oral progestin in Chinese patients. Gynecol Oncol. 2015 Dec;139(3):424-8. doi: 10.1016/j.ygyno.2015.09.078. Epub 2015 Sep 30. |
| 20934679 | Background | Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037. |
| 38425141 | Derived | Alnemr AA, Harb OA, Atia H. The efficacy of the levonorgestrel intrauterine system versus oral megestrol acetate in treating atypical endometrial hyperplasia: a superior randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e62. doi: 10.3802/jgo.2024.35.e62. Epub 2024 Feb 22. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |