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

Watson Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypogonadism

Treatments: Drug: testosterone matrix transdermal system

Study type: Interventional

Funder types: Industry

Identifiers

NCT01323140

TM1103

Details and patient eligibility

About

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

Full description

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

Enrollment: 40 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

TMTS treatment

Experimental group

Description:

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.

Treatment:

Drug: testosterone matrix transdermal system