atypical endometrial hyperplasia and endometrial carcinoma
Conditions
Interventions
Group 1 :LNG-IUD plus metformin
Group 2:megestrol acetate plus metformin
Sponsors
Shenyang Women's and Children's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Females with a BMI >24 wishing to retain fertility. 2.Over 18 years of age at time of randomisation and less than 45 years old. 3.No pregnancy contraindications. 4.Histologically confirmed complex EHA with atypia or grade 1 EC on a curette or endometrial biopsy. 5.CT scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease. 6.Myometrial invasion on MRI of not more than 50%, for women with suspected EC only. 7.No lymph vascular invasion on curetting. 8.Serum CA 125 <= 30 U/mL. 9.No hyper-sensitivity or contraindications for LNG-IUD,MA or metformin. 10.Ability to comply with endometrial biopsies at specified intervals. 11.No use of metformin for at least 2 years prior to enrolment. 12.No LNG-IU prior to enrolment. 13.No use of MAP prior to enrolment. 14.Planned treatment with the LNG-IU or MA for EHA or grade 1 EC by primary physician. 15.Women of childbearing potential must have negative pregnancy test within 7 days of D1 of treatment. 16.Understand study design, risks, and benefits and have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. ECOG score > 3; 2. Grade 1 EC, MRI shows that the depth of myometrial invasion exceeds 50%, or any grade 2 or 3 EC patients; 3. Histological (cellular) type, non-EC (sarcomas or high-risk endometrium, such as papillary serous clear cells); 4. Have a history of EC or EHA; 5. Those with a history of pelvic or abdominal radiotherapy; 6. Kidney damage (creatinine level over 150 µmol/l (1.7 mg/dL), acute pulmonary edema or liver failure, at the discretion of the investigator; 7. Unwilling to accept additional endometrial biopsy, or unable to participate in the three-month clinical assessment; 8. Unable to provide informed consent or a complete questionnaire; 9. Medical imaging shows evidence of extrauterine spread; 10. Congenital or acquired uterine deformity, which distorts the uterine cavity; 11. Acute pelvic inflammatory disease; 12. Combined with other cancers; 13. Chronic (daily use > 1 month) cimetidine (significantly increased metformin concentration, significantly increased risk of lactic acidosis); 14. Use of iodinated contrast medium within the first 48 hours (the concentration of metformin increases significantly, and the risk of lactic acidosis increases significantly); 15. Pregnancy or lactation; 16. A history of allergy to metformin or a history of secondary drug withdrawal due to adverse reactions; 17. High risk of thrombosis; 18. Had surgery last week; 19. Cerebral and/or myocardial infarction, thrombophlebitis or past history; 20. Valvular heart disease, atrial fibrillation, endocarditis or other serious heart disease; 21. Current management of hormone therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate;pregnancy outcome;recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood and tissue predictive biomarkers; | — |
Countries
China
Contacts
Public ContactXin Zhao
Shenyang Women's and Children's Hospital
Outcome results
None listed