KK Women's and Children's Hospital is recruiting patients for the clinical trial of A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore.
The investigators' objective is to determine the regression rate, side effects and acceptability of Mirena compared to megace in the treatment of atypical endometrial hyperplasia among women desiring fertility.
Atypical endometrial hyperplasia is a growing clinical problem that increases the risk of carcinogenesis and negatively impacts fertility. Although oral medical treatment may lead to regression in up to 90% of patients, they are associated with adverse side effects such as weight gain, that negatively affects fertility. To-date, there has been no RCTs evaluating the performance of the Mirena Intrauterine System (IUS) with megestrol acetate (megace) (the most effective and commonly used progestogen) in treating women with atypical hyperplasia who still desire fertility.
The researchers plan that January 3, 2020 will be the study start date. The indicative completion of the clinical trial will be expected in March 31, 2023.
Among primary outcome measures are the Time taken for regression of the disease and Participants will be reviewed in clinic every 3 months. An endometrial biopsy via hysteroscopy or bedside endometrial sampling will be performed to assess persistence, progression or resolution of the disease.
The study will take place at the National University Hospital, Singapore, Singapore; Singapore General Hospital, Singapore, Singapore; KK Women's and Children's Hospital, Singapore, Singapore.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05492487.