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

NCT05492487 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-03
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05492487 on ClinicalTrials.gov