The Efficacy of Levonorgestrel Intrauterine System Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia. A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- The success rate to accomplish complete regression of atypical endometrial hyperplasia
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
levonorgestrel intrauterine system (LNG-IUD)
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.
Intervention: levonorgestrel intrauterine system (LNG-IUD) (Device)
Megestrol acetate (MA)
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.
Intervention: Oral Megesterol 160 mg daily (Drug)
Outcomes
Primary Outcomes
The success rate to accomplish complete regression of atypical endometrial hyperplasia
Time Frame: 15 month
The success rate to accomplish complete regression of atypical endometrial hyperplasia
Secondary Outcomes
- a- Duration needed to accomplish the complete recovery(15 months)
- c- Differential response rates between premenopausal and postmenopausal cases.(15 months)
- d- The risk of thromboembolic complications(15 months)
- f- Metabolic complications rates(15 months)
- b- The partial regression and failure rates.(8 months)
Investigators
Hytham Atia
Associate Professor Obstetrics & Gynecology
Zagazig University