UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029540 |
|---|---|
| Receipt number | R000033750 |
| Scientific Title | Examination of the usefulness of testosterone cream for Late Onset Hypogonadism syndrome |
| Date of disclosure of the study information | 2017/10/13 |
| Last modified on | 2017/10/13 12:06:53 |
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Basic information
Public title
Examination of the usefulness of testosterone cream for Late Onset Hypogonadism syndrome
Acronym
Examination of the usefulness of testosterone cream for LOHsyndrome
Scientific Title
Examination of the usefulness of testosterone cream for Late Onset Hypogonadism syndrome
Scientific Title:Acronym
Examination of the usefulness of testosterone cream for LOHsyndrome
Region
| Japan |
Condition
Condition
LOH Syndrome
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to examine the effectiveness of testosterone replacement therapy (TRT) using AndroForte, a cream formulation as a treatment for LOH syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in AMS score at the start of treatment and after 12 weeks
Key secondary outcomes
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
AndroForte2
AndroForte5
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) AMS (Aging Male Symptom Scale) is 27 points or more
2) 12.5 pg / ml or less by free testosterone (RIA method)
3) Male patients aged 20 years or older at the time of consent acquisition
4) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will
5) Outpatient
Key exclusion criteria
1) Cases in which prostate specific antigen exceeds 4.0 ng / mL and the presence of prostate cancer can not be denied.
2) No treatment When the presence of severe sleep apnea syndrome is suspected. (Excluding examples of positive pressure ventilation therapy)
3) When hemoglobin has polycythemia of 18 g / dL or more
4) Cases in which severe cardiovascular lesions are suspected by echocardiography.
5) In addition, patients who are deemed inappropriate as researchers by the research director
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Hisasue |
Organization
Chibanisi-General Hospital
Division name
Urology
Zip code
Address
107-1,Kanegasaku,Matsudo-shi,Chiba,270-2251,japan
TEL
047-384-8111
tiken@chibanishi-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Hisasue |
Organization
Chibanisi-General Hospital
Division name
Urology
Zip code
Address
107-1,Kanegasaku,Matsudo-shi,Chiba,270-2251,japan
TEL
047-384-8111
Homepage URL
tiken@chibanishi-hp.or.jp
Sponsor or person
Institute
Chibanisi-General Hospital
Institute
Department
Personal name
Funding Source
Organization
Chibanisi-General Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 10 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 02 | 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
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2017 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033750
