Back to resultsMetformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia
Primary Purpose
Atypical Endometrial Hyperplasia
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Metformin plus Megestrol acetate
Megestrol Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Atypical Endometrial Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- 18-45 years old;
- pathologically diagnosed with AEH for the first time;
- desire to preserve their fertility;
- no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
- no contraindication for metformin, megestrol acetate or pregnancy;
- no hormone or metformin treatment within 6 months before entering the trial;
- not pregnant when participating in the trial;
- 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:
- allergy history or contraindications for megestrol acetate or metformin;
- pregnant when initiating the study;
- alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
- high risk of thrombosis;
- recurrent AEH;
- endometrial cancer;
- other malignancy history.
Sites / Locations
- Obstetrics and Gynecology Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin plus megestrol acetate
Megestrol acetate
Arm Description
Metformin 1500mg per day plus megestrol acetate 160mg per day.
Megestrol acetate 160mg per day.
Outcomes
Primary Outcome Measures
Complete response within 16 weeks of treatment
reversion of AEH The reversion of AEH to proliferative or secretory endometrium
Secondary Outcome Measures
Complete response within 32 weeks of treatment
The reversion of AEH to proliferative or secretory endometrium
Adverse events
Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone
2-year recurrence rate
recurrence rate within 2 years after the treatment
2-year pregnancy rate
Pregnancy rate within 2 years after the treatment
2-year live-birth rate
Live-birth rate within 2 years after the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04607252
Brief Title
Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia
Official Title
Comparing Metformin Plus Megestrol Acetate With Megestrol Acetate Alone as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
June 3, 2021 (Actual)
Study Completion Date
June 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Endometrial Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin plus megestrol acetate
Arm Type
Experimental
Arm Description
Metformin 1500mg per day plus megestrol acetate 160mg per day.
Arm Title
Megestrol acetate
Arm Type
Active Comparator
Arm Description
Megestrol acetate 160mg per day.
Intervention Type
Drug
Intervention Name(s)
Metformin plus Megestrol acetate
Intervention Description
metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
Intervention Type
Drug
Intervention Name(s)
Megestrol Acetate
Intervention Description
megestrol acetate 160mg per day, oral
Primary Outcome Measure Information:
Title
Complete response within 16 weeks of treatment
Description
reversion of AEH The reversion of AEH to proliferative or secretory endometrium
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Complete response within 32 weeks of treatment
Description
The reversion of AEH to proliferative or secretory endometrium
Time Frame
32 weeks
Title
Adverse events
Description
Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone
Time Frame
32 weeks
Title
2-year recurrence rate
Description
recurrence rate within 2 years after the treatment
Time Frame
2 years
Title
2-year pregnancy rate
Description
Pregnancy rate within 2 years after the treatment
Time Frame
2 years
Title
2-year live-birth rate
Description
Live-birth rate within 2 years after the treatment
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-45 years old;
pathologically diagnosed with AEH for the first time;
desire to preserve their fertility;
no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
no contraindication for metformin, megestrol acetate or pregnancy;
no hormone or metformin treatment within 6 months before entering the trial;
not pregnant when participating in the trial;
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:
allergy history or contraindications for megestrol acetate or metformin;
pregnant when initiating the study;
alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
high risk of thrombosis;
recurrent AEH;
endometrial cancer;
other malignancy history.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Chen, PHD
Organizational Affiliation
Obstetrics & Gynecology Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetrics and Gynecology Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared with other researchers without patients' personal information after all the findings being published.
Learn more about this trial
Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia
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