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To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate or LNG-IUS alone in patients with endometrial atypical hyperplasia.
After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before treatment to evacuate their metabolic conditions.
Patients are randomized to 1 of 3 treatment groups. Patients will receive MA (megestrol acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive LNG-IUS insertion on Arm II and MA 160 mg plus LNG-IUS insertion on Arm III. Then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. For patients with EAH, complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR, NR or PD.
After completion of study treatment, 2 months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MA | Active Comparator | Patients will receive megestrol acetate 160 mg by mouth daily for at least 3 months.Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded. |
|
| LNG-IUS | Active Comparator | Patients will receive LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded. |
|
| MA+LNG-IUS | Experimental | Patients will receive MA (160mg po qd) plus LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol Acetate | Drug | At a dosage of 160 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response rate | the proportion of histologic regression from endometrial atypical hyperplasia to benign endometrium | From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months |
| Pathological response time | time of histologic regression from endometrial atypical hyperplasia to benign endometrium | From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Common side effects from these drugs include weight gain, vaginal spotting and descent of sexuality. Severe side effects include thrombus and diseases related. The investigators will record any mental or body symptoms and evaluate the correlation. | up to 2 years after the treatment for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Economic consequences through study completion | The investigators will evaluate whether the combination could shorten the therapeutic period, so that bring economic benefits. | From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital, Fudan University | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26384790 | Background | Gressel GM, Parkash V, Pal L. Management options and fertility-preserving therapy for premenopausal endometrial hyperplasia and early-stage endometrial cancer. Int J Gynaecol Obstet. 2015 Dec;131(3):234-9. doi: 10.1016/j.ijgo.2015.06.031. Epub 2015 Sep 8. | |
| 23072814 | Background | Park JY, Kim DY, Kim JH, Kim YM, Kim KR, Kim YT, Seong SJ, Kim TJ, Kim JW, Kim SM, Bae DS, Nam JH. Long-term oncologic outcomes after fertility-sparing management using oral progestin for young women with endometrial cancer (KGOG 2002). Eur J Cancer. 2013 Mar;49(4):868-74. doi: 10.1016/j.ejca.2012.09.017. Epub 2012 Oct 13. |
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Study data are available after a request email with indications.
The data are available since the publication of the study paper.
The data can be accessed through email request.
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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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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Levonorgestrel-releasing Intrauterine System(LNG-IUS) | Device | Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system. |
|
|
| Rate of relapse | the proportion of experiencing recurrence after regression | up to 2 years after the treatment for each patient |
| Rate of pregnancy | the proportion of getting pregnancy after regression | up to 2 years after the treatment for each patient |
| Compliance | The investigators designed a questionnaire to evaluate the compliance through treatment as side effects of oral megestrol acetate may be more common than LNG-IUS. Self Efficacy, physical activity and social support will be scored (1 to 5) and compared among each arm. | up to 2 years after the treatment for each patient |
| 24286192 | Background | Orbo A, Vereide A, Arnes M, Pettersen I, Straume B. Levonorgestrel-impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial. BJOG. 2014 Mar;121(4):477-86. doi: 10.1111/1471-0528.12499. Epub 2013 Nov 28. |
| 17270370 | Background | Wildemeersch D, Janssens D, Pylyser K, De Wever N, Verbeeck G, Dhont M, Tjalma W. Management of patients with non-atypical and atypical endometrial hyperplasia with a levonorgestrel-releasing intrauterine system: long-term follow-up. Maturitas. 2007 Jun 20;57(2):210-3. doi: 10.1016/j.maturitas.2006.12.004. Epub 2007 Jan 31. |
| 11967486 | Background | Montz FJ, Bristow RE, Bovicelli A, Tomacruz R, Kurman RJ. Intrauterine progesterone treatment of early endometrial cancer. Am J Obstet Gynecol. 2002 Apr;186(4):651-7. doi: 10.1067/mob.2002.122130. |
| 26493012 | Background | Chen M, Jin Y, Li Y, Bi Y, Shan Y, Pan L. Oncologic and reproductive outcomes after fertility-sparing management with oral progestin for women with complex endometrial hyperplasia and endometrial cancer. Int J Gynaecol Obstet. 2016 Jan;132(1):34-8. doi: 10.1016/j.ijgo.2015.06.046. Epub 2015 Oct 1. |
| 37182434 | Derived | Xu Z, Yang B, Shan W, Liao J, Shao W, Wu P, Zhou S, Ning C, Luo X, Zhu Q, Zhang H, Ma F, Guan J, Chen X. Comparison of the effect of levonorgestrel-intrauterine system with or without oral megestrol acetate on fertility-preserving treatment in patients with atypical endometrial hyperplasia: A prospective, open-label, randomized controlled phase II study. Gynecol Oncol. 2023 Jul;174:133-141. doi: 10.1016/j.ygyno.2023.05.001. Epub 2023 May 12. |
| 32909630 | Derived | Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |