Atypical Endometrial Hyperplasia
Conditions
Brief summary
To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).
Detailed description
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.
Interventions
DRUGMetformin plus Megestrol acetate
metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
DRUGMegestrol Acetate
megestrol acetate 160mg per day, oral
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. 18-45 years old; 2. pathologically diagnosed with AEH for the first time; 3. desire to preserve their fertility; 4. no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS); 5. no contraindication for metformin, megestrol acetate or pregnancy; 6. no hormone or metformin treatment within 6 months before entering the trial; 7. not pregnant when participating in the trial; 8. willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.
Exclusion criteria
Patients who had one or more of the following conditions: 1. allergy history or contraindications for megestrol acetate or metformin; 2. pregnant when initiating the study; 3. alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney); 4. high risk of thrombosis; 5. recurrent AEH; 6. endometrial cancer; 7. other malignancy history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response within 16 weeks of treatment | 16 weeks | reversion of AEH The reversion of AEH to proliferative or secretory endometrium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response within 32 weeks of treatment | 32 weeks | The reversion of AEH to proliferative or secretory endometrium |
| Adverse events | 32 weeks | Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone |
| 2-year recurrence rate | 2 years | recurrence rate within 2 years after the treatment |
| 2-year pregnancy rate | 2 years | Pregnancy rate within 2 years after the treatment |
| 2-year live-birth rate | 2 years | Live-birth rate within 2 years after the treatment |
Countries
China
Outcome results
None listed