Clinical trial NCT04385667: LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia
Official title: The Efficacy of Levonorgestrel Intrauterine System Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atypical Endometrial Hyperplasia
Keywords: atypical endometrial hyperplasia
levonorgestrel intrauterine system
Megestrol acetate
partial regression
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-05-13
Enrollment: 143
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The success rate to accomplish complete regression of atypical endometrial hyperplasia
timeFrame: 15 month
Secondary outcomes:
measure: a- Duration needed to accomplish the complete recovery
timeFrame: 15 months
measure: b- The partial regression and failure rates.
timeFrame: 8 months
measure: c- Differential response rates between premenopausal and postmenopausal cases.
timeFrame: 15 months
measure: d- The risk of thromboembolic complications
timeFrame: 15 months
measure: f- Metabolic complications rates
timeFrame: 15 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
affiliation: Faculty of Medicine- Zagazig university
name: Amr Alnemr, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine- Zagazig university
name: Hytham Atia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.