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

Phase 2

Terminated

• Conditions: Atypical Endometrial Hyperplasia
• Interventions: Drug: Metformin plus Megestrol acetate; Drug: Megestrol Acetate

• Registration Number: NCT04607252
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2021-01-11
• Primary Completion: 2021-06-03
• Study Completion: 2021-06-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin plus megestrol acetate	Metformin plus Megestrol acetate	Metformin 1500mg per day plus megestrol acetate 160mg per day.
Megestrol acetate	Megestrol Acetate	Megestrol acetate 160mg per day.

Primary Outcome Measures

Name	Time	Method
Complete response within 16 weeks of treatment	16 weeks	reversion of AEH The reversion of AEH to proliferative or secretory endometrium

Secondary Outcome Measures

Name	Time	Method
2-year pregnancy rate	2 years	Pregnancy rate within 2 years after the treatment
Complete response within 32 weeks of treatment	32 weeks	The reversion of AEH to proliferative or secretory endometrium
2-year recurrence rate	2 years	recurrence rate within 2 years after the treatment
Adverse events	32 weeks	Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone
2-year live-birth rate	2 years	Live-birth rate within 2 years after the treatment

Trial Locations

Locations (1)

Obstetrics and Gynecology Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China