UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014958 |
|---|---|
| Receipt number | R000017405 |
| Scientific Title | Change of the serum hormone level in ultra-acute phase caused by the GnRH antagonist degarelix |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2014/08/26 17:05:30 |
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Basic information
Public title
Change of the serum hormone level in ultra-acute phase caused by the GnRH antagonist degarelix
Acronym
Change of the hormone level by degarelix
Scientific Title
Change of the serum hormone level in ultra-acute phase caused by the GnRH antagonist degarelix
Scientific Title:Acronym
Change of the hormone level by degarelix
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of the serum hormone level within 24hrs caused by degarelix
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The level of serum testosterone, Luteinizing hormone, Follicule-stimulating hormone within 24hrs after the injection of degarelix
Key secondary outcomes
Change of serum prostate specific antigen
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
Degarelix
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
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
Patholigically confirmed prostate cancer patients
Key exclusion criteria
Active urinary tract infection
Severe boiding dysfunction
Active other malignancies
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gaku Arai |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Urology
Zip code
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
+81-48-965-8743
g-arai@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gaku Arai |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Department of Urology
Zip code
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
+81-48-965-8743
Homepage URL
g-arai@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Dokkyo Medical University Koshigaya Hospital
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
| 2014 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 26 | Day |
Last modified on
| 2014 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017405
