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Trial record 87 of 213 for:    "Hypogonadism" | "Androgens"

Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

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ClinicalTrials.gov Identifier: NCT01104246
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 23, 2011
Last Update Posted : October 5, 2012
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: Testerone Transdermal System
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Testosterone Transdermal Systems
Hide Arm/Group Description Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Period Title: Overall Study
Started 40
Baseline Characteristics Measured 35
Completed 35
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
did not meet inclusion criteria             4
Arm/Group Title Testosterone Transdermal Systems
Hide Arm/Group Description Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  91.4%
>=65 years
3
   8.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
55.1  (8.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
0
   0.0%
Male
35
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
Hide Description A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
Time Frame Day 28/29
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Population was used for the analysis. PP population included subjects who completed the treatment period of the study, who did not have more than two consecutive missing data, and who did not have any major protocol deviations.
Arm/Group Title Testosterone Transdermal Systems
Hide Arm/Group Description:
Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: ng/dL
463  (122.1)
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone Transdermal Systems
Hide Arm/Group Description Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
All-Cause Mortality
Testosterone Transdermal Systems
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone Transdermal Systems
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%
Testosterone Transdermal Systems
Affected / at Risk (%) # Events
Total   9/40 (22.50%)    
Musculoskeletal and connective tissue disorders   
Back Pain  1  2/40 (5.00%)  2
Skin and subcutaneous tissue disorders   
Application site pruritus  1  6/40 (15.00%)  7
Application site vesicles  1  2/40 (5.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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: NCT01104246     History of Changes
Other Study ID Numbers: AND1001
First Submitted: April 13, 2010
First Posted: April 15, 2010
Results First Submitted: February 1, 2011
Results First Posted: February 23, 2011
Last Update Posted: October 5, 2012