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The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Metformin | Experimental | oral metformin at 500 mg twice a day for 14-21 days followed by surgery |
|
| Group 2 - No treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| IHC-based Tissue Markers of Proliferation | 1 year |
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Inclusion Criteria:
Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium
Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2
Candidate for surgical removal of their uterus as part of their endometrial cancer treatment
Subjects must have signed informed consent
Age 42 - 65 years of age
Electrocorticogram (ECOG) Performance status of 0 - 2
History of adequate renal, liver, and bone marrow function:
Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Subject eligibility was established before treatment randomization and included eligibility assessments, study assessments, lab tests, and pathology assessments.
Participants were recruited from the UAMS Gynecologic Oncology Clinic between August 2013 and July 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Metformin | oral metformin at 500 mg twice a day for 14-21 days followed by surgery Metformin |
| FG001 | Group 2 - No Treatment | no metformin for 14-21 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2016 | Sep 25, 2017 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Metformin | oral metformin at 500 mg twice a day for 14-21 days followed by surgery Metformin |
| BG001 | Group 2 - No Treatment | no metformin for 14-21 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IHC-based Tissue Markers of Proliferation | data were not collected | Posted | 1 year |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Metformin | oral metformin at 500 mg twice a day for 14-21 days followed by surgery Metformin | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | Group 2 - No Treatment | no metformin for 14-21 days | 0 | 4 | 0 | 4 | 0 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysuria | Renal and urinary disorders | Systematic Assessment | painful urination |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Scanlan | University of Arkansas for Medical Sciences | 5016868274 | BScanlan@uams.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2016 | Sep 25, 2017 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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