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Unique ID issued by UMIN UMIN000001011
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Teikyo University, School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001219

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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