NCT04385667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

2.5 years

First QC Date

May 9, 2020

Last Update Submit

December 30, 2022

Conditions

Atypical Endometrial Hyperplasia

Keywords

atypical endometrial hyperplasialevonorgestrel intrauterine systemMegestrol acetatepartial regression

Outcome Measures

Primary Outcomes (1)

  • The success rate to accomplish complete regression of atypical endometrial hyperplasia

    The success rate to accomplish complete regression of atypical endometrial hyperplasia

    15 month

Secondary Outcomes (5)

  • a- Duration needed to accomplish the complete recovery

    15 months

  • b- The partial regression and failure rates.

    8 months

  • c- Differential response rates between premenopausal and postmenopausal cases.

    15 months

  • d- The risk of thromboembolic complications

    15 months

  • f- Metabolic complications rates

    15 months

Study Arms (2)

levonorgestrel intrauterine system (LNG-IUD)

ACTIVE COMPARATOR

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)

Megestrol acetate (MA)

ACTIVE COMPARATOR

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

Interventions

levonorgestrel intrauterine system (LNG-IUD)DEVICE

progestin delivery for regression of atypical endometrial hyperplasia

Also known as: • 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.
levonorgestrel intrauterine system (LNG-IUD)
Oral Megesterol 160 mg dailyDRUG

progestin delivery for regression of atypical endometrial hyperplasia

Also known as: • 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.
Megestrol acetate (MA)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (5)

  • Armstrong AJ, Hurd WW, Elguero S, Barker NM, Zanotti KM. Diagnosis and management of endometrial hyperplasia. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):562-71. doi: 10.1016/j.jmig.2012.05.009. Epub 2012 Aug 3.

    PMID: 22863972BACKGROUND

  • Salman MC, Usubutun A, Boynukalin K, Yuce K. Comparison of WHO and endometrial intraepithelial neoplasia classifications in predicting the presence of coexistent malignancy in endometrial hyperplasia. J Gynecol Oncol. 2010 Jun;21(2):97-101. doi: 10.3802/jgo.2010.21.2.97. Epub 2010 Jun 30.

    PMID: 20613899BACKGROUND

  • Zhou R, Yang Y, Lu Q, Wang J, Miao Y, Wang S, Wang Z, Zhao C, Wei L. Prognostic factors of oncological and reproductive outcomes in fertility-sparing treatment of complex atypical hyperplasia and low-grade endometrial cancer using oral progestin in Chinese patients. Gynecol Oncol. 2015 Dec;139(3):424-8. doi: 10.1016/j.ygyno.2015.09.078. Epub 2015 Sep 30.

    PMID: 26428941BACKGROUND

  • Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037.

    PMID: 20934679BACKGROUND

  • Alnemr AA, Harb OA, Atia H. The efficacy of the levonorgestrel intrauterine system versus oral megestrol acetate in treating atypical endometrial hyperplasia: a superior randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e62. doi: 10.3802/jgo.2024.35.e62. Epub 2024 Feb 22.

    PMID: 38425141DERIVED

MeSH Terms

Conditions

Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Amr Alnemr, M.D.

    Faculty of Medicine- Zagazig university

    PRINCIPAL INVESTIGATOR

  • Hytham Atia, M.D.

    Faculty of Medicine- Zagazig university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Obstetrics & Gynecology

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 13, 2020

Study Start

May 20, 2020

Primary Completion

December 1, 2022

Study Completion

December 25, 2022

Last Updated

January 3, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)