NCT04385667

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Atypical Endometrial Hyperplasia

Interventions

Type	Name	Description
DEVICE	levonorgestrel intrauterine system (LNG-IUD)	progestin delivery for regression of atypical endometrial hyperplasia
DRUG	Oral Megesterol 160 mg daily	progestin delivery for regression of atypical endometrial hyperplasia

Timeline

• Start date: 2020-05-20
• Primary completion: 2022-12-01
• Completion: 2022-12-25
• First posted: 2020-05-13
• Last updated: 2023-01-03

Locations

1 site across 1 country: Egypt