NCT05492487

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

April 7, 2022

Last Update Submit

August 5, 2022

Conditions

Endometrial HyperplasiaFertility IssuesDisease RegressionTreatment Side Effects

Keywords

Endometrial HyperplasiaFertilityDisease RegressionRandomised Clinical TrialMirena IUSMegace

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Patient Acceptability

    Review in 3rd months.

  • Patient Acceptability

    Review in 6th months.

  • Patient Acceptability

    Review in 9th months.

  • Side Effects

    Through study completion, an average of 9 months.

Study Arms (2)

Mirena Arm

EXPERIMENTAL

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.

Drug: Mirena

Megace Arm

EXPERIMENTAL

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.

Drug: Megace

Interventions

MirenaDRUG

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.

Mirena Arm
MegaceDRUG

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.

Megace Arm

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All women diagnosed with atypical hyperplasia aged 21 years to 40 years
  • Keen for fertility-preserving treatment

You may not qualify if:

  • Patients who are currently undergoing treatment for atypical hyperplasia
  • Patients with a history of endometrial carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (1)

  • Goh CSY, Loh MJM, Lim WW, Ang JX, Nadarajah R, Yong TT, Tong P, Yeo YC, Phoon JWL. A multi-centre randomised controlled trial comparing megestrol acetate to levonorgestrel-intrauterine system in fertility sparing treatment of atypical endometrial hyperplasia. J Assist Reprod Genet. 2024 Sep;41(9):2485-2494. doi: 10.1007/s10815-024-03172-z. Epub 2024 Aug 31.

    PMID: 39215793DERIVED

MeSH Terms

Conditions

Endometrial HyperplasiaInfertility

Interventions

LevonorgestrelMegestrol Acetate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMegestrolPregnadienesPregnanes

Central Study Contacts

Jessie Phoon, Dr

CONTACT

98242158jessie.phoon.w.l@singhealth.com.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomised into either the megace group or the Mirena group. There will be sealed envelopes containing a paper with either Mirena or megace printed on each of them. Participants can chose an envelope at random. The patient and PI will not be blinded of the selection in the study.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2022

First Posted

August 8, 2022

Study Start

January 3, 2020

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(3)