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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

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.

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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).

Conditions

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Hypogonadism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMTS treatment

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.

Group Type EXPERIMENTAL

testosterone matrix transdermal system

Intervention Type DRUG

Interventions

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testosterone matrix transdermal system

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No