UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002210 |
|---|---|
| Receipt number | R000002716 |
| Scientific Title | A pilot study of the medroxyprogesterone + metformin combination therapy for the endometrial cancer |
| Date of disclosure of the study information | 2009/07/16 |
| Last modified on | 2015/01/15 23:40:08 |
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Basic information
Public title
A pilot study of the medroxyprogesterone + metformin combination therapy for the endometrial cancer
Acronym
A pilot study of the medroxyprogesterone + metformin combination therapy for the endometrial cancer
Scientific Title
A pilot study of the medroxyprogesterone + metformin combination therapy for the endometrial cancer
Scientific Title:Acronym
A pilot study of the medroxyprogesterone + metformin combination therapy for the endometrial cancer
Region
| Japan |
Condition
Condition
endometrial cancer
atypical endometrial hyperplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We confirm whether the metformin prevents a recurrence after the MPA.
We confirm whether the metformin improves a pregnancy rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence free interval
Key secondary outcomes
Primary complete response rate
Pregnancy rate
Side effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were scheduled to received 400mg per day of medroxyprogesterone acetate with 100mg of aspirin orally on a daily basis for 24weeks.
The metformin combines concurrently.
We administer the metformin from start 750mg per day and increase in quantity to 2,250mg per day without a side effect
The patients take metformin continuously for four years
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Histrogically confirmed well differentiated endometrioid adenocarcinoma at presumed stage IA and atypical endometrial hyperplasia
(2) myometrium invasion was ruled out by MRI
(3)performance status of 0 to 1
(4) serum creatinine <1.0mg/dl
(5) A case without hypersensitivity for this treatment use medicine
(6) The case that written informed consent was obtained before participation
Key exclusion criteria
(1) The case with a history of the hypersensitivity that is serious for this study use medicine or the drug allergy
(2)A history of the lactic acidosis
(3)Patients on dialysis
(4)Shock, failure heart, myocardial infarction, a cardiovascular injury including the pulmonary embolism
(5)Excessive alcohol intake
(6)Hepatic dysfunction
(7) A history of the thrombosis
(8)A case with the psychic disturbance that it seems that we need in the treatment or treatment with antimental medicine
(9) Patients with diabetes
(10)A case with the double cancer of the activity
(11)In addition, the case that the chief physician judged to be inadequate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makio Shozu |
Organization
Graduate School of Medicine, Chiba University
Division name
reproductive medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
shozu@faculty.chbia-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Mitsuhashi |
Organization
Graduate School of Medicine, Chiba University
Division name
Reproductive medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
antira@faculty.chbia-u.jp
Sponsor or person
Institute
chiba university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 15 | Day |
Last modified on
| 2015 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002716
