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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323140
First Posted: March 25, 2011
Last Update Posted: January 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Watson Pharmaceuticals
March 21, 2011
March 25, 2011
October 2, 2012
January 1, 2013
January 1, 2013
April 2011
July 2011   (Final data collection date for primary outcome measure)
Percent of Subjects With Testosterone Levels in the Normal Range. [ Time Frame: Day 29/30 ]
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.
Average Testosterone Serum Concentration (Cavg) [ Time Frame: Day 29/30 ]
Cavg will be calculated from the serum concentration data and the serum samples will be obtained at the Day 29/30 of the study.
Complete list of historical versions of study NCT01323140 on ClinicalTrials.gov Archive Site
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Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
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
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).
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypogonadism
Drug: testosterone matrix transdermal system
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.
Intervention: Drug: testosterone matrix transdermal system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01323140
TM1103
No
Not Provided
Not Provided
Watson Pharmaceuticals
Watson Pharmaceuticals
Not Provided
Study Director: Keshava Kumar, PhD, MHSA Watson Pharmaceuticals
Watson Pharmaceuticals
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP