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

Phase 2

Completed

• Conditions: Atypical Endometrial Hyperplasia
• Interventions: Device: levonorgestrel intrauterine system (LNG-IUD); Drug: Oral Megesterol 160 mg daily

• Registration Number: NCT04385667
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-09
• Study First Posted: 2020-05-13
• Study Start: 2020-05-20
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-25
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levonorgestrel intrauterine system (LNG-IUD)	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.
Megestrol acetate (MA)	Oral Megesterol 160 mg daily	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.

Primary Outcome Measures

Name	Time	Method
The success rate to accomplish complete regression of atypical endometrial hyperplasia	15 month	The success rate to accomplish complete regression of atypical endometrial hyperplasia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt