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Trial record 79 of 213 for:    "Hypogonadism" | "Androgens"

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

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.
 
ClinicalTrials.gov Identifier: NCT01323140
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypogonadism
Intervention Drug: testosterone matrix transdermal system
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 40
Completed 38
Not Completed 2
Arm/Group Title Treatment
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
49.1  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
0
   0.0%
Male
40
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Percent of Subjects With Testosterone Levels in the Normal Range.
Hide Description 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.
Time Frame Day 29/30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68.4
(53.6 to 83.2)
Time Frame First test article administration to study exit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%) # Events
Total   6/40 (15.00%)    
General disorders   
Application site irritation  1  3/40 (7.50%)  4
Nervous system disorders   
Headache  1  3/40 (7.50%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Organization: Watson Laboratories, Inc.
Phone: 801-588-6641
EMail: gary.hoel@watson.com
Layout table for additonal information
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01323140     History of Changes
Other Study ID Numbers: TM1103
First Submitted: March 21, 2011
First Posted: March 25, 2011
Results First Submitted: October 2, 2012
Results First Posted: January 1, 2013
Last Update Posted: January 1, 2013