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

This study has been completed.
Information provided by (Responsible Party):
Watson Pharmaceuticals Identifier:
First received: March 21, 2011
Last updated: November 30, 2012
Last verified: November 2012

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

Condition Intervention Phase
Drug: testosterone matrix transdermal system
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Percent of Subjects With Testosterone Levels in the Normal Range. [ Time Frame: Day 29/30 ] [ Designated as safety issue: No ]
    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.

Enrollment: 40
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: testosterone matrix transdermal system

Detailed Description:

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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01323140

United States, Florida
Watson Investigational Site
Ft. Meyers, Florida, United States
United States, Washington
Watson Investigational Site
Tacoma, Washington, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Study Director: Keshava Kumar, PhD, MHSA Watson Pharmaceuticals
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals Identifier: NCT01323140     History of Changes
Other Study ID Numbers: TM1103
Study First Received: March 21, 2011
Results First Received: October 2, 2012
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
hypogonadism, testosterone, transdermal system

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents processed this record on April 17, 2014