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

Watson Pharmaceuticals40 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism

Interventions

testosterone matrix transdermal systemDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Watson Investigational Site

Fort Meyers, Florida, United States

Watson Investigational Site

Tacoma, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 29/30

Data from ClinicalTrials.gov

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