Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
111

Inclusion Criteria

No hypersensitivity or contraindications for Mirena
Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
...
No hypersensitivity or contraindications for Mirena
Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
Serum CA125 ≤ 30 U/mL
Females with a BMI > 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
Ability to comply with endometrial biopsies at specified intervals
No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample
CT or MRI scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
Over 18 years of age at time of randomisation
Creatinine < 150µmol/L (1.7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5.4 Other Eligibility Criteria Considerations)

Exclusion Criteria

Unable or unwilling to complete questionnaires
Genital actinomycosis
Patients with a history of pelvic or abdominal radiotherapy
...
Unable or unwilling to complete questionnaires
Genital actinomycosis
Patients with a history of pelvic or abdominal radiotherapy
Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
Congenital or acquired uterine anomaly which distorts the uterine cavity
Unable to provide informed consent
Breastfeeding mothers
Previous use of Mirena within the last 5 years from randomisation/enrolment
Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments
Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis
Contraindications to both Metformin and weight loss
Pregnant or planning to become pregnant during trial period
ECOG performance status > 3
Evidence of extrauterine spread on medical imaging
Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
Acute pelvic inflammatory disease
Mirena inserted greater than 12 weeks before randomisation/enrolment
Has had prior treatment or undergoing current treatment for EAC or EHA

Summary

Conditions
  • Complex Endometrial Hyperplasia With Atypia
  • Grade 1 Endometrial Endometrioid Adenocarcinoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Inclusion Criteria

No hypersensitivity or contraindications for Mirena
Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
...
No hypersensitivity or contraindications for Mirena
Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
Serum CA125 ≤ 30 U/mL
Females with a BMI > 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
Ability to comply with endometrial biopsies at specified intervals
No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample
CT or MRI scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
Over 18 years of age at time of randomisation
Creatinine < 150µmol/L (1.7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5.4 Other Eligibility Criteria Considerations)

Exclusion Criteria

Unable or unwilling to complete questionnaires
Genital actinomycosis
Patients with a history of pelvic or abdominal radiotherapy
...
Unable or unwilling to complete questionnaires
Genital actinomycosis
Patients with a history of pelvic or abdominal radiotherapy
Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
Congenital or acquired uterine anomaly which distorts the uterine cavity
Unable to provide informed consent
Breastfeeding mothers
Previous use of Mirena within the last 5 years from randomisation/enrolment
Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments
Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis
Contraindications to both Metformin and weight loss
Pregnant or planning to become pregnant during trial period
ECOG performance status > 3
Evidence of extrauterine spread on medical imaging
Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
Acute pelvic inflammatory disease
Mirena inserted greater than 12 weeks before randomisation/enrolment
Has had prior treatment or undergoing current treatment for EAC or EHA

Tracking Information

NCT #
NCT01686126
Collaborators
  • The University of Queensland
  • Queensland University of Technology
Investigators
Study Chair: Andreas Obermair Queensland Centre for Gynaecological Cancer