The efficacy and safety of 2.5% testosterone gel for late-onset hypogonadsism patients evaluated by using salivary testosterone.

UMIN ID: UMIN000001011

Registered date:10/02/2008

Basic Information

• Health condition(s) or Problem(s) studied: Late-onset hypogonadism
• Date of first enrollment: 2008/02/01
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
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.
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.
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.

Outcome(s)

• Primary Outcome: Serum hormone profiles,salivary testosterone, AMS score.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 90years-old
• Gender: Male
• Exclude criteria: Patients having serious heart, iver, and renal dysfunction. Pasients who have serious pshychiatric problems are also excluded.

Related Information

• Primary Sponsor: Teikyo University, School of Medicine
• Source(s) of Monetary Support: Inovation