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

Primary Purpose

Endometrial Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
Norethisterone Acetate tablets
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring Endometrial hyperplasia,, LNG-IUS,, Progestin

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Hospitals,OB/GYN department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LNG-IUS

Norethisterone Acetate

Arm Description

Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.

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

Outcomes

Primary Outcome Measures

Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.

Secondary Outcome Measures

Time to achieve complete regression

Full Information

First Posted
December 20, 2011
Last Updated
December 22, 2011
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01499602
Brief Title
Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Official Title
LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia
Keywords
Endometrial hyperplasia,, LNG-IUS,, Progestin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LNG-IUS
Arm Type
Experimental
Arm Description
Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.
Arm Title
Norethisterone Acetate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland
Intervention Description
Initial release rate of 20µg Levonorgestrel per day for one year follow up.
Intervention Type
Drug
Intervention Name(s)
Norethisterone Acetate tablets
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
Time Frame
At 3 and 6 months
Secondary Outcome Measure Information:
Title
Time to achieve complete regression
Time Frame
During the follow up period at 3,6,12 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD. MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals,OB/GYN department
City
Mansoura
State/Province
Dakahlia Governorate
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
19300331
Citation
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.
Results Reference
background
PubMed Identifier
20613900
Citation
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.
Results Reference
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Learn more about this trial

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

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