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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01323140
First received: March 21, 2011
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Hypogonadism
 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:

U.S. FDA Resources

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).

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01323140

Locations
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
Investigators
Study Director: Keshava Kumar, PhD, MHSA Watson Pharmaceuticals
  More Information

No publications provided

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov 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:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on June 18, 2013