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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323140
• Other study ID #: TM1103
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: November 30, 2012
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: November 2012
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• testosterone matrix transdermal system

Locations

Country	Name	City	State
United States	Watson Investigational Site	Ft. Meyers	Florida
United States	Watson Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No