A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore
Overview
- Phase
- Phase 2
- Intervention
- Mirena
- Conditions
- Endometrial Hyperplasia
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Rate of Regression
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Phoon Wai Leng Jessie
Assistant Professor
KK Women's and Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •All women diagnosed with atypical hyperplasia aged 21 years to 40 years
- •Keen for fertility-preserving treatment
Exclusion Criteria
- •Patients who are currently undergoing treatment for atypical hyperplasia
- •Patients with a history of endometrial carcinoma
Arms & Interventions
Mirena Arm
The patients in the Mirena arm will have a Mirena inserted at time of recruitment of the study. An endometrial biopsy will be performed to assess for disease progression, regression or persistence after 3 months. The endometrial biopsy will be performed via bedside endometrial sampling or hysteroscopic biopsy. As Mirena can be used for treatment of atypical hyperplasia as well as endometrial protection (decreases the risk of endometrial hyperplasia recurrence), the option of keeping or changing the Mirena during biopsy will be discussed with the patient.
Intervention: Mirena
Megace Arm
The patients in the megace arm will have be prescribed 3 months of oral megace at time of recruitment of the study. An endometrial biopsy will be performed to assess for disease progression, regression or persistence after 3 months. The endometrial biopsy will be performed via bedside endometrial sampling or hysteroscopic biopsy.
Intervention: Megace
Outcomes
Primary Outcomes
Rate of Regression
Time Frame: Review in 3 months, maximum up to 9 months of treatment.
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.
Time taken for regression of the disease
Time Frame: Review in 3 months, maximum up to 9 months of treatment.
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.
Secondary Outcomes
- Side Effects(Through study completion, an average of 9 months.)
- Patient Acceptability(Review in 9th months.)