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

NCT ID: NCT04607252

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-06-03

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.

Conditions

Atypical Endometrial Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metformin plus megestrol acetate

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

Group Type: EXPERIMENTAL

Metformin plus Megestrol acetate

Intervention Type: DRUG

metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral

Megestrol acetate

Megestrol acetate 160mg per day.

Group Type: ACTIVE_COMPARATOR

Megestrol Acetate

Intervention Type: DRUG

megestrol acetate 160mg per day, oral

Interventions

Metformin plus Megestrol acetate

metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral

Intervention Type: DRUG

Megestrol Acetate

megestrol acetate 160mg per day, oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Chen

Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics & Gynecology Hospital of Fudan University

Locations

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

V01 2020-10

Identifier Type: -

Identifier Source: org_study_id