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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2022-12-25

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.

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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

Conditions

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Atypical Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

levonorgestrel intrauterine system (LNG-IUD)

Intervention Type DEVICE

progestin delivery for regression of atypical endometrial hyperplasia

Megestrol acetate (MA)

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.

Group Type ACTIVE_COMPARATOR

Oral Megesterol 160 mg daily

Intervention Type DRUG

progestin delivery for regression of atypical endometrial hyperplasia

Interventions

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levonorgestrel intrauterine system (LNG-IUD)

progestin delivery for regression of atypical endometrial hyperplasia

Intervention Type DEVICE

Oral Megesterol 160 mg daily

progestin delivery for regression of atypical endometrial hyperplasia

Intervention Type DRUG

Other Intervention Names

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• 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. • 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.

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No