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NCT Number: NCT04385667

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

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

levonorgestrel intrauterine system (LNG-IUD)

Device

progestin delivery for regression of atypical endometrial hyperplasia

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.

Oral Megesterol 160 mg daily

Drug

progestin delivery for regression of atypical endometrial hyperplasia

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.

Primary outcomes

  1. The success rate to accomplish complete regression of atypical endometrial hyperplasia

    Time frame: 15 month

    The success rate to accomplish complete regression of atypical endometrial hyperplasia

Secondary outcomes

  1. a- Duration needed to accomplish the complete recovery

    Time frame: 15 months

    time till regression

  2. b- The partial regression and failure rates.

    Time frame: 8 months

    incidence of partial regression and therapy failure

  3. c- Differential response rates between premenopausal and postmenopausal cases.

    Time frame: 15 months

    response rate in both premenopause and postmenopause women

  4. d- The risk of thromboembolic complications

    Time frame: 15 months

    incidence of thromboembolism with therapy

  5. f- Metabolic complications rates

    Time frame: 15 months

    occurence of diabetes or hypertension ...ets

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 13, 2020
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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