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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Atypical Endometrial Hyperplasia

Intervention / Treatment
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* Device: levonorgestrel intrauterine system (LNG-IUD)
* Drug: Oral Megesterol 160 mg daily


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levonorgestrel intrauterine system (LNG-IUD)<br>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)<br>* progestin delivery for regression of atypical endometrial hyperplasia<br>* 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)<br>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<br>* progestin delivery for regression of atypical endometrial hyperplasia<br>* 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atypical endometrial hyperplasia, levonorgestrel intrauterine system, Megestrol acetate, partial regression