LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia

December 30, 2022 updated by: Hytham Atia, Zagazig University

The Efficacy of Levonorgestrel Intrauterine System Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia. A Randomized Controlled Trial.

This randomized controlled trial is aimed to compare the efficacy between Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD) regarding the ability and duration to produce complete regression for cases with atypical endometrial hyperplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Up to 25% of cases with endometrial cancer and atypical hyperplasia occur in premenopausal women. The progressively increasing trend of delay in first conception increases such patients who wish to have children.3 The recommended treatment for EH without atypia is primarily hormonal, whereas the preferred treatment for EH with atypia is hysterectomy given the significant risk for both concurrent and subsequent development of endometrial carcinoma. A dilemma results when EH with atypia is diagnosed in women who wish to retain fertility or declining doing hysterectomy due to concomitant medical morbidities. In these women, a trial of hormone therapy can be considered.4,5 In recent years, progestin therapy has been successfully used to treat selected women with endometrial cancer and atypical hyperplasia who desire to preserve fertility or having severe medical co-morbidities precluding (immediate) surgery. The most common progestin regimens include Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD).5-7

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44511
        • Zagazig University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy

Exclusion Criteria:

  • Cases with evidence of associated endometrial cancer.
  • Cases with simple hyperplasia without atypia.
  • Patients failed to collect at least 2 endometrial samples during treatment course.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: levonorgestrel intrauterine system (LNG-IUD)

levonorgestrel intrauterine system (LNG-IUD) applied.

  • Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.
  • Patients with persistent atypical hyperplasia in specimens done after 6 months of start of therapy will be considered resistant to therapy and hysterectomy will be done.
  • Primary and secondary outcome data will be collected in tables with the other demographic data. All will be processed in tables for statistical analysis.
Device: levonorgestrel intrauterine system (LNG-IUD)
progestin delivery for regression of atypical endometrial hyperplasia
Other Names:
  • • Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.
Active Comparator: Megestrol acetate (MA)

Megesterol arm will receive 160 mg daily

  • Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.
  • Patients with persistent atypical hyperplasia in specimens done after 6 months of start of therapy will be considered resistant to therapy and hysterectomy will be done.
  • Primary and secondary outcome data will be collected in tables with the other demographic data. All will be processed in tables for statistical analysis.
Drug: Oral Megesterol 160 mg daily
progestin delivery for regression of atypical endometrial hyperplasia
Other Names:
  • • Follow up endometrial sampling will be scheduled for all study patients in 3 months manner for at least one year. Specimens will be reviewed by single expert pathologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate to accomplish complete regression of atypical endometrial hyperplasia
Time Frame: 15 month
The success rate to accomplish complete regression of atypical endometrial hyperplasia
15 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a- Duration needed to accomplish the complete recovery
Time Frame: 15 months
time till regression
15 months
b- The partial regression and failure rates.
Time Frame: 8 months
incidence of partial regression and therapy failure
8 months
c- Differential response rates between premenopausal and postmenopausal cases.
Time Frame: 15 months
response rate in both premenopause and postmenopause women
15 months
d- The risk of thromboembolic complications
Time Frame: 15 months
incidence of thromboembolism with therapy
15 months
f- Metabolic complications rates
Time Frame: 15 months
occurence of diabetes or hypertension ...ets
15 months

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Amr Alnemr, M.D., Faculty of medicine- Zagazig University
  • Principal Investigator: Hytham Atia, M.D., Faculty of medicine- Zagazig 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 (Actual)

May 20, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 25, 2022

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVN-IUS vs Megace for AEH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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