Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

Fudan University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Atypical Endometrial Hyperplasia

Treatments: Drug: Megestrol Acetate; Drug: Metformin plus Megestrol acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT04607252

V01 2020-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Metformin plus megestrol acetate

Experimental group

Description:

Metformin 1500mg per day plus megestrol acetate 160mg per day.

Treatment:

Drug: Metformin plus Megestrol acetate

Megestrol acetate

Active Comparator group

Description:

Megestrol acetate 160mg per day.

Treatment:

Drug: Megestrol Acetate