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Atypical Endometrial HyperplasiaPhase 2/3NCT04385667

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

A Phase 2/3 study testing levonorgestrel intrauterine system (LNG-IUD) and Oral Megesterol 160 mg daily in people with Atypical Endometrial Hyperplasia, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Atypical Endometrial Hyperplasia
What is being tested?
levonorgestrel intrauterine system (LNG-IUD) and Oral Megesterol 160 mg daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteEgypt
Study dates
20 May 2020to 25 Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

  • Zagazig University

    Zagazig, Sharqia Province, 44511

Other trials in Egypt

About this study

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

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.

Read the 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

Being tested
levonorgestrel intrauterine system (LNG-IUD), Oral Megesterol 160 mg daily
Keywords
atypical endometrial hyperplasia, levonorgestrel intrauterine system, Megestrol acetate, partial regression
Medical subject headings
Endometrial Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • levonorgestrel intrauterine system (LNG-IUD)Device

    Also called • 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.

    progestin delivery for regression of atypical endometrial hyperplasia

  • Oral Megesterol 160 mg dailyDrug

    Also called • 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.

    progestin delivery for regression of atypical endometrial hyperplasia

Study groups in NCT04385667
Study groupRoleWhat they receive
levonorgestrel intrauterine system (LNG-IUD)Active comparatorlevonorgestrel 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.
Receives: Device: levonorgestrel intrauterine system (LNG-IUD)
Megestrol acetate (MA)Active comparatorMegesterol 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.
Receives: Drug: Oral Megesterol 160 mg daily

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The success rate to accomplish complete regression of atypical endometrial hyperplasia

    Measured: 15 month

Secondary outcomes (5)

  1. a- Duration needed to accomplish the complete recovery

    time till regression

    Measured: 15 months

  2. b- The partial regression and failure rates.

    incidence of partial regression and therapy failure

    Measured: 8 months

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

    response rate in both premenopause and postmenopause women

    Measured: 15 months

  4. d- The risk of thromboembolic complications

    incidence of thromboembolism with therapy

    Measured: 15 months

  5. f- Metabolic complications rates

    occurence of diabetes or hypertension ...ets

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start20 May 2020
  3. Primary completion1 Dec 2022
  4. Study completion25 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04385667
Sponsor's protocol ID
LVN-IUS vs Megace for AEH
Status last verified
Dec 2022
First submitted
9 May 2020
Last updated
3 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Armstrong AJ, Hurd WW, Elguero S, Barker NM, Zanotti KM. Diagnosis and management of endometrial hyperplasia. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):562-71. doi: 10.1016/j.jmig.2012.05.009. Epub 2012 Aug 3.

    PubMed 22863972

  • Salman MC, Usubutun A, Boynukalin K, Yuce K. Comparison of WHO and endometrial intraepithelial neoplasia classifications in predicting the presence of coexistent malignancy in endometrial hyperplasia. J Gynecol Oncol. 2010 Jun;21(2):97-101. doi: 10.3802/jgo.2010.21.2.97. Epub 2010 Jun 30.

    PubMed 20613899

  • Zhou R, Yang Y, Lu Q, Wang J, Miao Y, Wang S, Wang Z, Zhao C, Wei L. Prognostic factors of oncological and reproductive outcomes in fertility-sparing treatment of complex atypical hyperplasia and low-grade endometrial cancer using oral progestin in Chinese patients. Gynecol Oncol. 2015 Dec;139(3):424-8. doi: 10.1016/j.ygyno.2015.09.078. Epub 2015 Sep 30.

    PubMed 26428941

  • Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037.

    PubMed 20934679

  • Alnemr AA, Harb OA, Atia H. The efficacy of the levonorgestrel intrauterine system versus oral megestrol acetate in treating atypical endometrial hyperplasia: a superior randomized controlled trial. J Gynecol Oncol. 2024 Sep;35(5):e62. doi: 10.3802/jgo.2024.35.e62. Epub 2024 Feb 22.

    PubMed 38425141

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing levonorgestrel intrauterine system (LNG-IUD) and Oral Megesterol 160 mg daily in people with Atypical Endometrial Hyperplasia, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The success rate to accomplish complete regression of atypical endometrial hyperplasia (time frame: 15 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04385667, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.

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