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

December 22, 2011 updated by: Hatem AbuHashim, Mansoura University

LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
Time Frame: At 3 and 6 months
At 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to achieve complete regression
Time Frame: During the follow up period at 3,6,12 months after treatment
During the follow up period at 3,6,12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 26, 2011

Last Update Submitted That Met QC Criteria

December 22, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-324v

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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