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

Fertility Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492487
• Other study ID #: CIRB 2019/2551
• Status: Recruiting
• Phase: Phase 2
• Start date: January 3, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2022
• Source: KK Women's and Children's Hospital
• Contact: Jessie Phoon, Dr
• Phone: 98242158
• Email: jessie.phoon.w.l[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Fertility Issues
• Hyperplasia
• Infertility
• Treatment Side Effects

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Regression	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.	Review in 3 months, maximum up to 9 months of treatment.
Primary	Time taken for regression of the disease	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.	Review in 3 months, maximum up to 9 months of treatment.
Secondary	Patient Acceptability	Number of participants who are keen to continue their current treatment or change the treatment, at the end of 3rd months follow-up.	Review in 3rd months.
Secondary	Patient Acceptability	Number of participants who are keen to continue their current treatment or change the treatment, at the end of 6th months follow-up.	Review in 6th months.
Secondary	Patient Acceptability	Number of participants who are keen to continue their current treatment or change the treatment, at the end of 9th months follow-up.	Review in 9th months.
Secondary	Side Effects	Number of participants with side effects such as irregular bleeding, nausea/bloatedness or acne.	Through study completion, an average of 9 months.