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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002210
Receipt No. 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

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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
Obsterics 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
Email 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
Email antira@faculty.chbia-u.jp

Sponsor
Institute chiba university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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