Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hatem AbuHashim, Mansoura University

ClinicalTrials.gov Identifier:

NCT01499602

First received: December 20, 2011

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

Purpose

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.

Condition	Intervention
Endometrial Hyperplasia	Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland Drug: Norethisterone Acetate tablets

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

Resource links provided by NLM:

Drug Information available for: Norethindrone acetate Norethindrone Levonorgestrel

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:

Change in endometrial histopathology pattern from endometrial hyperplasia into regression status. [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achieve complete regression [ Time Frame: During the follow up period at 3,6,12 months after treatment ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	May 2009
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LNG-IUS Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.	Drug: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland Initial release rate of 20µg Levonorgestrel per day for one year follow up.
Active Comparator: Norethisterone Acetate 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	Drug: Norethisterone Acetate tablets 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

Eligibility

Ages Eligible for Study:	40 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499602

Locations

Egypt
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt, 35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator:

Hatem Abu Hashim, MD. MRCOG

Mansoura University Hospitals

More Information

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.

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. Epub 2010 Jun 30.

Responsible Party:	Hatem AbuHashim, Associate Professor of Obstetrics & Gynecology., Mansoura University
ClinicalTrials.gov Identifier:	NCT01499602 History of Changes
Other Study ID Numbers:	MU-324v
Study First Received:	December 20, 2011
Last Updated:	December 22, 2011
Health Authority:	Egypt: Institutional Review Board

Keywords provided by Mansoura University:

Endometrial hyperplasia,
LNG-IUS,
Progestin

Additional relevant MeSH terms:

Endometrial Hyperplasia
Hyperplasia
Adenoma
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Levonorgestrel

Norethindrone
Norethindrone acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013

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