Trial Outcomes & Findings for Testosterone Treatment for Hypogonadal Men (NCT NCT00433199)
NCT ID: NCT00433199
Last Updated: 2015-01-27
Results Overview
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
COMPLETED
PHASE3
274 participants
Day 112
2015-01-27
Participant Flow
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%.
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.
Participant milestones
| Measure |
Placebo
Placebo comparator administered during the Double-Blind period only
|
T-Gel 1.62%
Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
|
|---|---|---|
|
Double-Blind Period
STARTED
|
40
|
234
|
|
Double-Blind Period
COMPLETED
|
28
|
168
|
|
Double-Blind Period
NOT COMPLETED
|
12
|
66
|
|
Open-Label Period
STARTED
|
0
|
219
|
|
Open-Label Period
COMPLETED
|
0
|
185
|
|
Open-Label Period
NOT COMPLETED
|
0
|
34
|
Reasons for withdrawal
| Measure |
Placebo
Placebo comparator administered during the Double-Blind period only
|
T-Gel 1.62%
Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
|
|---|---|---|
|
Double-Blind Period
Adverse Event
|
0
|
25
|
|
Double-Blind Period
Lack of Efficacy
|
0
|
2
|
|
Double-Blind Period
Lost to Follow-up
|
2
|
5
|
|
Double-Blind Period
Withdrawal by Subject
|
8
|
19
|
|
Double-Blind Period
Protocol Violation
|
1
|
10
|
|
Double-Blind Period
Administrative
|
1
|
5
|
|
Open-Label Period
Adverse Event
|
0
|
19
|
|
Open-Label Period
Lack of Efficacy
|
0
|
2
|
|
Open-Label Period
Lost to Follow-up
|
0
|
3
|
|
Open-Label Period
Withdrawal by Subject
|
0
|
7
|
|
Open-Label Period
Protocol Violation
|
0
|
2
|
|
Open-Label Period
Administrative
|
0
|
1
|
Baseline Characteristics
Testosterone Treatment for Hypogonadal Men
Baseline characteristics by cohort
| Measure |
Placebo
n=37 Participants
Placebo comparator administered during the Double-Blind period only
|
T-Gel 1.62%
n=214 Participants
Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
7 participants
n=99 Participants
|
34 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Age, Customized
45-54 years
|
7 participants
n=99 Participants
|
83 participants
n=107 Participants
|
90 participants
n=206 Participants
|
|
Age, Customized
55-64 years
|
16 participants
n=99 Participants
|
67 participants
n=107 Participants
|
83 participants
n=206 Participants
|
|
Age, Customized
>= 65 years
|
7 participants
n=99 Participants
|
30 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
214 participants
n=107 Participants
|
251 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 112Population: 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;
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
Outcome measures
| Measure |
T-Gel 1.62%
n=179 Participants
Testosterone gel 1.62% given during the double-blind period.
|
Placebo
n=27 Participants
Placebo Comparator given during the double-blind period.
|
Combined (CA and FP)
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
|
|---|---|---|---|
|
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
|
81.6 Percentage of subjects
Interval 75.1 to 87.0
|
37.0 Percentage of subjects
Interval 19.4 to 57.6
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.
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
Outcome measures
| Measure |
T-Gel 1.62%
n=210 Participants
Testosterone gel 1.62% given during the double-blind period.
|
Placebo
n=37 Participants
Placebo Comparator given during the double-blind period.
|
Combined (CA and FP)
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
|
|---|---|---|---|
|
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
|
65.7 Percentage of subjects
Interval 58.9 to 72.1
|
29.7 Percentage of subjects
Interval 15.9 to 47.0
|
—
|
SECONDARY outcome
Timeframe: Day 56Population: The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.
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
Outcome measures
| Measure |
T-Gel 1.62%
n=183 Participants
Testosterone gel 1.62% given during the double-blind period.
|
Placebo
n=32 Participants
Placebo Comparator given during the double-blind period.
|
Combined (CA and FP)
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
|
|---|---|---|---|
|
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
|
82.5 Percentage of subjects
Interval 76.2 to 87.7
|
34.4 Percentage of subjects
Interval 18.6 to 53.2
|
—
|
SECONDARY outcome
Timeframe: Day 182Population: The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.
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.
Outcome measures
| Measure |
T-Gel 1.62%
n=169 Participants
Testosterone gel 1.62% given during the double-blind period.
|
Placebo
n=28 Participants
Placebo Comparator given during the double-blind period.
|
Combined (CA and FP)
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
|
|---|---|---|---|
|
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
|
82.2 Percentage of subjects
Interval 75.6 to 87.7
|
28.6 Percentage of subjects
Interval 13.2 to 48.7
|
—
|
SECONDARY outcome
Timeframe: Day 266Population: The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.
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%.
Outcome measures
| Measure |
T-Gel 1.62%
n=139 Participants
Testosterone gel 1.62% given during the double-blind period.
|
Placebo
n=26 Participants
Placebo Comparator given during the double-blind period.
|
Combined (CA and FP)
n=165 Participants
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
|
|---|---|---|---|
|
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
|
78.4 Percentage of subjects
Interval 70.6 to 84.9
|
69.2 Percentage of subjects
Interval 48.2 to 85.7
|
77.0 Percentage of subjects
Interval 69.8 to 83.2
|
SECONDARY outcome
Timeframe: Day 364Population: The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.
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%.
Outcome measures
| Measure |
T-Gel 1.62%
n=136 Participants
Testosterone gel 1.62% given during the double-blind period.
|
Placebo
n=23 Participants
Placebo Comparator given during the double-blind period.
|
Combined (CA and FP)
n=159 Participants
Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
|
|---|---|---|---|
|
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
|
77.9 Percentage of subjects
Interval 70.0 to 84.6
|
87.0 Percentage of subjects
Interval 66.4 to 97.2
|
79.2 Percentage of subjects
Interval 72.1 to 85.3
|
Adverse Events
Placebo
T-Gel 1.62%
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
Placebo comparator administered during the Double-Blind period only
|
T-Gel 1.62%
n=234 participants at risk
Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/40 • 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).
|
0.43%
1/234 • 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).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/40 • 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).
|
0.43%
1/234 • 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).
|
|
Eye disorders
Retinal Detachment
|
2.5%
1/40 • 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).
|
0.00%
0/234 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/40 • 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).
|
0.43%
1/234 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumour
|
0.00%
0/40 • 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).
|
0.43%
1/234 • 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).
|
|
Nervous system disorders
Spinal cord and nerve root disorders
|
0.00%
0/40 • 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).
|
0.43%
1/234 • 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).
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Placebo comparator administered during the Double-Blind period only
|
T-Gel 1.62%
n=234 participants at risk
Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
|
|---|---|---|
|
Infections and infestations
Bacterial infections NEC
|
5.0%
2/40 • 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).
|
0.00%
0/234 • 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).
|
|
Infections and infestations
Upper respiratory tract infections
|
5.0%
2/40 • 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).
|
8.5%
20/234 • 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).
|
|
Investigations
Cell marker procedures
|
0.00%
0/40 • 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).
|
11.1%
26/234 • 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).
|
|
Nervous system disorders
Headaches NEC
|
5.0%
2/40 • 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).
|
3.0%
7/234 • 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).
|
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER