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Trial record 84 of 213 for:    "Hypogonadism" | "Androgens"

Testosterone Treatment for Hypogonadal Men

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ClinicalTrials.gov Identifier: NCT00433199
Recruitment Status : Completed
First Posted : February 9, 2007
Results First Posted : December 8, 2011
Last Update Posted : January 27, 2015
Sponsor:
Information provided by:
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypogonadism
Interventions Drug: Testosterone (T) Gel 1.62%
Drug: Placebo
Enrollment 274
Recruitment Details Subjects were recruited in 63 centers in US from February 2007 to April 2007 in clinics. The study was designed with a double-blind period of 182 days on Placebo or Androgel 1.62% followed by an 182 days open-label period on Androgel 1.62%.
Pre-assignment Details All subjects started at a daily dose of 2.50 g testosterone gel 1.62% or matching placebo on Day 1. Within 2 days of each of visits (D14, D28 and D42), the dose was titrated up or down in 1.25 g steps if necessary, based on pre-specified normal range criteria, by an unblinded reviewer. The minimum and maximum daily doses were 1.25 g and 5.0 g.
Arm/Group Title Placebo T-Gel 1.62%
Hide Arm/Group Description Placebo comparator administered during the Double-Blind period only Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
Period Title: Double-Blind Period
Started 40 234
Completed 28 168
Not Completed 12 66
Reason Not Completed
Adverse Event             0             25
Lack of Efficacy             0             2
Lost to Follow-up             2             5
Withdrawal by Subject             8             19
Protocol Violation             1             10
Administrative             1             5
Period Title: Open-Label Period
Started 0 219
Completed 0 185
Not Completed 0 34
Reason Not Completed
Adverse Event             0             19
Lack of Efficacy             0             2
Lost to Follow-up             0             3
Withdrawal by Subject             0             7
Protocol Violation             0             2
Administrative             0             1
Arm/Group Title Placebo T-Gel 1.62% Total
Hide Arm/Group Description Placebo comparator administered during the Double-Blind period only Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period. Total of all reporting groups
Overall Number of Baseline Participants 37 214 251
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 214 participants 251 participants
<45 years 7 34 41
45-54 years 7 83 90
55-64 years 16 67 83
>= 65 years 7 30 37
[1]
Measure Description: The Baseline analysis is presented on the Full analysis set.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 214 participants 251 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
37
 100.0%
214
 100.0%
251
 100.0%
[1]
Measure Description: The Baseline analysis is presented on the Full analysis set.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 214 participants 251 participants
37 214 251
[1]
Measure Description: The Baseline analysis is presented on the Full analysis set.
1.Primary Outcome
Title Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
Hide Description Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results
Time Frame Day 112
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112;
Arm/Group Title T-Gel 1.62% Placebo
Hide Arm/Group Description:
Testosterone gel 1.62% given during the double-blind period.
Placebo Comparator given during the double-blind period.
Overall Number of Participants Analyzed 179 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
81.6
(75.1 to 87.0)
37.0
(19.4 to 57.6)
2.Secondary Outcome
Title Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
Hide Description Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.
Arm/Group Title T-Gel 1.62% Placebo
Hide Arm/Group Description:
Testosterone gel 1.62% given during the double-blind period.
Placebo Comparator given during the double-blind period.
Overall Number of Participants Analyzed 210 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
65.7
(58.9 to 72.1)
29.7
(15.9 to 47.0)
3.Secondary Outcome
Title Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
Hide Description Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.
Arm/Group Title T-Gel 1.62% Placebo
Hide Arm/Group Description:
Testosterone gel 1.62% given during the double-blind period.
Placebo Comparator given during the double-blind period.
Overall Number of Participants Analyzed 183 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
82.5
(76.2 to 87.7)
34.4
(18.6 to 53.2)
4.Secondary Outcome
Title Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
Hide Description Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.
Time Frame Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.
Arm/Group Title T-Gel 1.62% Placebo
Hide Arm/Group Description:
Testosterone gel 1.62% given during the double-blind period.
Placebo Comparator given during the double-blind period.
Overall Number of Participants Analyzed 169 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
82.2
(75.6 to 87.7)
28.6
(13.2 to 48.7)
5.Secondary Outcome
Title Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
Hide Description The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Time Frame Day 266
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.
Arm/Group Title Continuing Active T-Gel 1.62% (CA) Formerly Placebo (FP) Combined (CA and FP)
Hide Arm/Group Description:
Testosterone gel 1.62% given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
Placebo group given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
Overall Number of Participants Analyzed 139 26 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
78.4
(70.6 to 84.9)
69.2
(48.2 to 85.7)
77.0
(69.8 to 83.2)
6.Secondary Outcome
Title Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
Hide Description The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Time Frame Day 364
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.
Arm/Group Title Continuing Active T-Gel 1.62% (CA) Formerly Placebo (FP) Combined (CA and FP)
Hide Arm/Group Description:
Testosterone gel 1.62% given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
Placebo given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
Overall Number of Participants Analyzed 136 23 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
77.9
(70.0 to 84.6)
87.0
(66.4 to 97.2)
79.2
(72.1 to 85.3)
Time Frame The adverse events presented were collected from start of drug treatment to the end of the double-blind treatment period (from Day 0 to Day 182).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo T-Gel 1.62%
Hide Arm/Group Description Placebo comparator administered during the Double-Blind period only Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
All-Cause Mortality
Placebo T-Gel 1.62%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo T-Gel 1.62%
Affected / at Risk (%) Affected / at Risk (%)
Total   1/40 (2.50%)   5/234 (2.14%) 
Cardiac disorders     
Myocardial infarction * 1  0/40 (0.00%)  1/234 (0.43%) 
Tachycardia * 1  0/40 (0.00%)  1/234 (0.43%) 
Eye disorders     
Retinal Detachment * 1  1/40 (2.50%)  0/234 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  0/40 (0.00%)  1/234 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pituitary Tumour * 1  0/40 (0.00%)  1/234 (0.43%) 
Nervous system disorders     
Spinal cord and nerve root disorders * 1  0/40 (0.00%)  1/234 (0.43%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo T-Gel 1.62%
Affected / at Risk (%) Affected / at Risk (%)
Total   5/40 (12.50%)   47/234 (20.09%) 
Infections and infestations     
Bacterial infections NEC * 1  2/40 (5.00%)  0/234 (0.00%) 
Upper respiratory tract infections * 1  2/40 (5.00%)  20/234 (8.55%) 
Investigations     
Cell marker procedures * 1  0/40 (0.00%)  26/234 (11.11%) 
Nervous system disorders     
Headaches NEC * 1  2/40 (5.00%)  7/234 (2.99%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-91110
Layout table for additonal information
Responsible Party: Michael Miller, Pharm. D Project Director, Abbott
ClinicalTrials.gov Identifier: NCT00433199     History of Changes
Other Study ID Numbers: S176.3.104
First Submitted: February 8, 2007
First Posted: February 9, 2007
Results First Submitted: May 27, 2011
Results First Posted: December 8, 2011
Last Update Posted: January 27, 2015