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

Atypical Endometrial Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385667
• Other study ID #: LVN-IUS vs Megace for AEH
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Endometrial Hyperplasia
• Hyperplasia

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