NCT05492487

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Hyperplasia
• Fertility Issues
• Disease Regression
• Treatment Side Effects

Interventions

Type	Name	Description
DRUG	Mirena	Mirena Intrauterine System (Mirena-IUS) is a levonorgestrel-releasing intrauterine system. Mirena consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir (hormone elastomer core) around the vertical stem. The reservoir consists of a white or almost white cylinder, made of a mixture of levonorgestrel and silicone (polydimethylsiloxane), containing a total of 52 mg levonorgestrel. Mirena is approved for intrauterine contraception and in 2009 to treat heavy periods for women who choose intrauterine contraception. Mirena is often used off-label for the treatment of endometrial hyperplasia. Levonorgestrel is a progestogen used in a variety of contraceptive products. Low doses of levonorgestrel can be administered into the uterine cavity with the Mirena intrauterine delivery system. Mirena has mainly local progestogenic effects in the uterine cavity.
DRUG	Megace	Megestrol acetate (Megace) is a synthetic derivative of the natural occurring steroid hormone, progesterone. It is licensed for the treatment of anorexia, cachexia or unexplained weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) and palliative treatment of advanced breast or endometrial cancer. Megace is often used off-label for the treatment of endometrial hyperplasia. While the precise mechanism by which Megace produces its antineoplastic effects against endometrial carcinoma and endometrial hyperplasia is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. There is evidence to suggest a local effect as a result of the marked changes brought about by the direct instillation of progestational agents into the endometrial cavity.

Timeline

• Start date: 2020-01-03
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-08-08
• Last updated: 2022-08-08

Locations

3 sites across 1 country: Singapore