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

Zagazig University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Atypical Endometrial Hyperplasia

Treatments: Drug: Oral Megesterol 160 mg daily; Device: levonorgestrel intrauterine system (LNG-IUD)

Study type: Interventional

Funder types: Other

Identifiers

NCT04385667

LVN-IUS vs Megace for AEH

Details and patient eligibility

About

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.

Full 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

Enrollment: 143 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

levonorgestrel intrauterine system (LNG-IUD)

Active Comparator group

Description:

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.

Treatment:

Device: levonorgestrel intrauterine system (LNG-IUD)

Megestrol acetate (MA)

Active Comparator group

Description:

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.

Treatment:

Drug: Oral Megesterol 160 mg daily