A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore

Phase 2

• Conditions: Endometrial Hyperplasia; Fertility Issues; Disease Regression; Treatment Side Effects
• Interventions: Drug: Mirena; Drug: Megace

• Registration Number: NCT05492487
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study Start: 2020-01-03
• Study First Submitted: 2022-04-07
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-05
• Last Update Submitted: 2022-08-05
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirena Arm	Mirena	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.
Megace Arm	Megace	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.

Primary Outcome Measures

Name	Time	Method
Rate of Regression	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	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 Outcome Measures

Name	Time	Method
Side Effects	Through study completion, an average of 9 months.	Number of participants with side effects such as irregular bleeding, nausea/bloatedness or acne.
Patient Acceptability	Review in 9th months.	Number of participants who are keen to continue their current treatment or change the treatment, at the end of 9th months follow-up.

Trial Locations

Locations (3)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore