Hypogonadism
Conditions
Keywords
Hypogonadism, Testosterone Deficiency
Brief summary
Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men
Interventions
DRUGTestosterone (T) Gel 1.62%
Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
DRUGPlacebo
Placebo Control
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Low T males 18 - 80 years of age
Exclusion criteria
* Normal T levels * Elevated Prostatic Specific Antigen (PSA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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. |
| Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | 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%. |
| Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. | 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%. |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo comparator administered during the Double-Blind period only | 37 |
| 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. | 214 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind Period | Administrative | 1 | 5 |
| 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 | Protocol Violation | 1 | 10 |
| Double-Blind Period | Withdrawal by Subject | 8 | 19 |
| Open-Label Period | Administrative | 0 | 1 |
| 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 | Protocol Violation | 0 | 2 |
| Open-Label Period | Withdrawal by Subject | 0 | 7 |
Baseline characteristics
| Characteristic | Placebo | T-Gel 1.62% | Total |
|---|---|---|---|
| Age, Customized 45-54 years | 7 participants | 83 participants | 90 participants |
| Age, Customized <45 years | 7 participants | 34 participants | 41 participants |
| Age, Customized 55-64 years | 16 participants | 67 participants | 83 participants |
| Age, Customized >= 65 years | 7 participants | 30 participants | 37 participants |
| Region of Enrollment United States | 37 participants | 214 participants | 251 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 214 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 40 | 47 / 234 |
| serious Total, serious adverse events | 1 / 40 | 5 / 234 |
Outcome results
Primary
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
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| T-Gel 1.62% | 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 |
| Placebo | 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 | 37.0 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period 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%.
Time frame: Day 266
Population: The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Gel 1.62% | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | 78.4 Percentage of subjects |
| Placebo | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | 69.2 Percentage of subjects |
| Combined (CA and FP) | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | 77.0 Percentage of subjects |
Secondary
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period 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%.
Time frame: Day 364
Population: The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Gel 1.62% | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. | 77.9 Percentage of subjects |
| Placebo | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. | 87.0 Percentage of subjects |
| Combined (CA and FP) | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. | 79.2 Percentage of subjects |
Secondary
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
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
Population: The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Gel 1.62% | 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 |
| Placebo | 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 | 29.7 Percentage of subjects |
Secondary
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
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
Population: The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Gel 1.62% | 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 |
| Placebo | 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 | 28.6 Percentage of subjects |
Secondary
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
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
Population: The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-Gel 1.62% | 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 |
| Placebo | 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 | 34.4 Percentage of subjects |