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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04385667
Other study ID # LVN-IUS vs Megace for AEH
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 20, 2020
Est. completion date December 25, 2022

Study information

Verified date December 2022
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date December 25, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Device:
levonorgestrel intrauterine system (LNG-IUD)
progestin delivery for regression of atypical endometrial hyperplasia
Drug:
Oral Megesterol 160 mg daily
progestin delivery for regression of atypical endometrial hyperplasia

Locations

Country Name City State
Egypt Zagazig University Zagazig Sharkia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 a- Duration needed to accomplish the complete recovery time till regression 15 months
Secondary b- The partial regression and failure rates. incidence of partial regression and therapy failure 8 months
Secondary c- Differential response rates between premenopausal and postmenopausal cases. response rate in both premenopause and postmenopause women 15 months
Secondary d- The risk of thromboembolic complications incidence of thromboembolism with therapy 15 months
Secondary f- Metabolic complications rates occurence of diabetes or hypertension ...ets 15 months
See also
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Active, not recruiting NCT03671811 - Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy Phase 2
Completed NCT00490087 - Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women Phase 3
Terminated NCT04607252 - Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia Phase 2/Phase 3
Recruiting NCT05051722 - Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Active, not recruiting NCT00892866 - CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells N/A
Recruiting NCT03463252 - Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC Phase 2/Phase 3