Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

Study Overview
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Brief Summary
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Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

Detailed Description
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The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).

Official Title
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An Open Label, Dose-Proportionality, Bioavailability and Dose- Titration Investigation of the Pharmacokinetics, Metabolism, Efficacy and Safety of Two Testosterone Matrix Transdermal Systems (28 cm2 and 48 cm2) in Hypogonadal Men

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: testosterone matrix transdermal system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, 18 - 65 years of age; Documented testosterone deficiency; BMI 18 to 33. Exclusion Criteria: Evidence of prostate cancer and benign prostate hyperplasia; Taking medications that interfere testosterone metabolism; History of alcohol or drug substance abuse; Abnormal ECG; Allergic to transdermal products; Skin condition that interfere transdermal system application and assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMTS treatment<br>Following a lead-in dose-proportionality phase (Days 1-2) and a site-to-site bioavailability phase (Days 2-9), subjects were dosed for efficacy analysis beginning on Day 9 at dose level B (a single 48 cm2 testosterone matrix transdermal system). Based on pharmacokinetic (PK) analysis of blood samples drawn on Day 16, on Day 22 subjects could be dose-titrated up to dose level C (one 28 cm2 plus one 48 cm2 TMTS), down to dose level A (one 28 cm2 TMTS), or remain at dose level B. Subjects at all dose levels were pooled for primary efficacy analysis on Days 29/30. | Drug: testosterone matrix transdermal system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With Testosterone Levels in the Normal Range. | Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (>= 300 ng/dL to <= 1030 ng/dL), at least 85% of subjects with Cmax <= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax >= 2500 ng/dL. | Day 29/30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypogonadism, testosterone, transdermal system