UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001011 |
|---|---|
| Receipt number | R000001219 |
| Scientific Title | The efficacy and safety of 2.5% testosterone gel for late-onset hypogonadsism patients evaluated by using salivary testosterone. |
| Date of disclosure of the study information | 2008/02/10 |
| Last modified on | 2008/02/03 14:40:15 |
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Basic information
Public title
The efficacy and safety of 2.5% testosterone gel for late-onset hypogonadsism patients evaluated by using salivary testosterone.
Acronym
The efficacy of 2.5% testosterone gel for late-onset hypogonadsism patients
Scientific Title
The efficacy and safety of 2.5% testosterone gel for late-onset hypogonadsism patients evaluated by using salivary testosterone.
Scientific Title:Acronym
The efficacy of 2.5% testosterone gel for late-onset hypogonadsism patients
Region
| Japan |
Condition
Condition
Late-onset hypogonadism
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Late-onset hypogonadism (LOH) is due to age-related steep declines in free testosterone levels in middle age. LOH can induce a variety of signs and symptoms such as somatic, psychological and sexual dysfunctions which deteriorate the quality of life (QOL) of middle-aged men. Despite a high prevalence, many LOH patients are not diagnosed and treated. Unlike in western countries, in Japan, only testosterone injection is covered by the health insurance. It tends to keep LOH patients from testosterone supplementation. First, in the case of testosterone injection, the blood concentration of testosterone is much more changeable than testosterone gel or tablets. Next, it is not convenient for LOH patients to come to a hospital to get injection every 2 or 3 weeks. In addition, an injection is more harmful and invasive than gel or tablets. Taken together, in Japan, testosterone supplementation has not become popular, which should be beneficial for Japanese aging society.
We assume that the effective and convenient testosterone gel will be able to be accepted and keep high compliance which contribute to graceful aging by reducing long term health problems. The aim of this study is to seek the best volume, efficacy and safety of 2.5% testosterone gel for Japanese LOH patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum hormone profiles,salivary testosterone, AMS score.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Examination of the circadian change and the highest time point of salivary testosterone levels after using testosterone gel.
Subjects are provided with plastic sterile screw sputum processors to collect samples at two hourly intervals between 7am and 9pm. Subjects are asked to finish eating and brushing their teeth at least one hour before saliva sampling in order to avoid food and blood contamination. Subjects rinse their mouths with water three times and wait a few minutes, then expectorate at least 1 ml of saliva directly into a collection vial. In order to compare the testosterone circadian rhythm and to determine when the testosterone levels get the highest levels after using testosterone gel, baseline and after using testosterone gel is determined in the following way.
The first day,not using testosterone.
The second day,subjects are asked to apply 1mg of 2.5% testosterone gel on their inner parts of thighs.
To be on the safe side, salivary samples are measured by ELISA.
Interventions/Control_2
Determination of the safety and most effective amount of gel.
The same subjects in the protocol 1, are asked to apply 0.7g, 1.0g, and 1.3g of gel at 7 am after collection of saliva and to collect saliva at the time when salivary testosterone levels are highest in protocol 1. For each amount of gel, they are asked not to use gel for 2 days for washout period.
The amount by which the highest testosterone levels of all sample are between 50pg/ml~150pg/ml is considered the safest and the most effective amount.
Interventions/Control_3
Examination of the difference in the safety and efficacy in different age.
Each 5 of LOH patients in 40-59, 60-79 and 80and over is recruited. They are asked to apply the best amount defined by protocol 2 at 7 am immediately after collection of saliva. Then they are asked to collect saliva sample at the best time determine by protocol 1. This test will demonstrate whether or not the seemingly safest and the most effective amount in protocol 2 is available for all generations.
Interventions/Control_4
Evaluation of safety of chronic treatment with 2.5% testosterone gel.
5 of subjects are treated for 60 days by the defined amount of testosterone gel by previous protocols.
They take medical check, including blood examination (hemoglobin, lever function, PSA, hormone profiles) and salivary examination at the base line, after 3 and 6 months. They are also asked about side effects such as skin symptoms at each visit.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
Late-onst hypogonadism patients at the age of 40to 80.
Key exclusion criteria
Patients having serious heart, iver, and renal dysfunction. Pasients who have serious pshychiatric problems are also excluded.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuko Yasuda |
Organization
Teikyo University, School of Medicine
Division name
Department of Urology
Zip code
Address
2-11-1, kaga, Itabashi-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Teikyo University, School of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Teikyo University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Inovation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2008 | Year | 02 | Month | 10 | 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
Date of protocol fixation
| 2008 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 03 | Day |
Last modified on
| 2008 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001219
