Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04385667
Study type Interventional
Source Zagazig University
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 20, 2020
Completion date December 25, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02397083 - Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer Phase 2
Recruiting NCT05647109 - Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
Completed NCT04491682 - Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia Phase 2/Phase 3
Active, not recruiting NCT00788671 - Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer Phase 2
Withdrawn NCT01943058 - Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer Phase 2
Withdrawn NCT04683237 - Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Completed NCT00483327 - Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate Phase 2
Recruiting NCT05316493 - Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Completed NCT03241888 - Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia Phase 2/Phase 3
Recruiting NCT06379113 - GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients Phase 2/Phase 3
Recruiting NCT06390904 - GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients Phase 2/Phase 3
Recruiting NCT05316935 - GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients Phase 2/Phase 3
Recruiting NCT05172999 - Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Recruiting NCT05675787 - Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia Phase 2
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