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The purpose of this study is to compare the efficacy of the Levonorgestrel releasing Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical endometrial hyperplasia in perimenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LNG-IUS | Experimental | Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up. |
|
| Norethisterone Acetate | Active Comparator | Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland | Drug | Initial release rate of 20µg Levonorgestrel per day for one year follow up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in endometrial histopathology pattern from endometrial hyperplasia into regression status. | At 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve complete regression | During the follow up period at 3,6,12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hatem Abu Hashim, MD. MRCOG | Mansoura University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals,OB/GYN department | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19300331 | Background | Reed SD, Voigt LF, Newton KM, Garcia RH, Allison HK, Epplein M, Jordan D, Swisher E, Weiss NS. Progestin therapy of complex endometrial hyperplasia with and without atypia. Obstet Gynecol. 2009 Mar;113(3):655-662. doi: 10.1097/AOG.0b013e318198a10a. | |
| 20613900 | Background | Lee SY, Kim MK, Park H, Yoon BS, Seong SJ, Kang JH, Jun HS, Park CT. The effectiveness of levonorgestrel releasing intrauterine system in the treatment of endometrial hyperplasia in Korean women. J Gynecol Oncol. 2010 Jun;21(2):102-5. doi: 10.3802/jgo.2010.21.2.102. 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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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D000077563 | Norethindrone Acetate |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Norethisterone Acetate tablets | Drug | Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009640 | Norethindrone |