Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Hyperplasia
Intervention: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland (Drug); Norethisterone Acetate tablets (Drug)
Phase: N/A
Status: Completed
Sponsored by: Mansoura University Official(s) and/or principal investigator(s): Hatem Abu Hashim, MD. MRCOG, Principal Investigator, Affiliation: Mansoura University Hospitals
Summary
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.
Clinical Details
Official title: LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
Secondary outcome: Time to achieve complete regression
Eligibility
Minimum age: 40 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients with histologically confirmed simple or complex endometrial hyperplasia
without atypia
Exclusion Criteria:
- Endometrial hyperplasia with atypia
- Other pathology e. g. patients with fibroids of any size, genital infection, adnexal
abnormality.
Locations and Contacts
Mansoura University Hospitals,OB/GYN department, Mansoura, Dakahlia Governorate 35511, Egypt
Additional Information
Related publications: 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):655-62. doi: 10.1097/AOG.0b013e318198a10a. 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.
Starting date: May 2009
Last updated: December 22, 2011
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