To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).
Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
megestrol acetate 160mg per day, oral
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Complete response within 16 weeks of treatment
reversion of AEH The reversion of AEH to proliferative or secretory endometrium
Time frame: 16 weeks
Complete response within 32 weeks of treatment
The reversion of AEH to proliferative or secretory endometrium
Time frame: 32 weeks
Adverse events
Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone
Time frame: 32 weeks
2-year recurrence rate
recurrence rate within 2 years after the treatment
Time frame: 2 years
2-year pregnancy rate
Pregnancy rate within 2 years after the treatment
Time frame: 2 years
2-year live-birth rate
Live-birth rate within 2 years after the treatment
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.