Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia

• Status: Recruiting
• Trial end date: 2027-02-28
• Target enrollment: 0
• Participant gender: Female

Summary

To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Megestrol; Megestrol Acetate; Metformin

Criteria

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.