A Phase 2/3 interventional study of levonorgestrel intrauterine system (LNG-IUD) and Oral Megesterol 160 mg daily in Atypical Endometrial Hyperplasia, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2023-01-03.
Sponsored by Zagazig University · Phase 2/3, Interventional, and Treatment
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.
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
103 studies on the registry are indexed under Endometrial Hyperplasia; 35 are open to participants now.
This study's enrollment of 143 is above the median of 76 across 66 interventional studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy
Exclusion Criteria:
levonorgestrel 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.
Device: levonorgestrel intrauterine system (LNG-IUD)
Megesterol 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.
Drug: Oral Megesterol 160 mg daily
progestin delivery for regression of atypical endometrial hyperplasia
Also known as: • 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
Also known as: • 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.
The success rate to accomplish complete regression of atypical endometrial hyperplasia
The success rate to accomplish complete regression of atypical endometrial hyperplasia
Time frame: 15 month
a- Duration needed to accomplish the complete recovery
time till regression
Time frame: 15 months
b- The partial regression and failure rates.
incidence of partial regression and therapy failure
Time frame: 8 months
c- Differential response rates between premenopausal and postmenopausal cases.
response rate in both premenopause and postmenopause women
Time frame: 15 months
d- The risk of thromboembolic complications
incidence of thromboembolism with therapy
Time frame: 15 months
f- Metabolic complications rates
occurence of diabetes or hypertension ...ets
Time frame: 15 months
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Zagazig University