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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

Page last updated: August 23, 2015

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