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Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| T-Gel 1.62% | Experimental | Testosterone (T) gel 1.62% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone (T) Gel 1.62% | Drug | Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Abbott Products | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22321357 | Derived | Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9. |
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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.
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%.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo comparator administered during the Double-Blind period only |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Period |
|
| |||||||||||||||||||||
| Open-Label Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo comparator administered during the Double-Blind period only |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The Baseline analysis is presented on the Full analysis set. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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; | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 112 |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo comparator administered during the Double-Blind period only |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial infections NEC | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-91110 |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Placebo Control |
|
| Day 14 |
| 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 | Day 56 |
| 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. | Day 182 |
| 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%. | Day 266 |
| 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%. | Day 364 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Administrative |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | The Baseline analysis is presented on the Full analysis set. | Count of Participants | Participants |
|
| Region of Enrollment | The Baseline analysis is presented on the Full analysis set. | Number | participants |
|
Testosterone gel 1.62% given during the double-blind period. |
| OG001 | Placebo | Placebo Comparator given during the double-blind period. |
|
|
| 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 | The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 14 |
|
|
|
| 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 | The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 56 |
|
|
|
| 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. | The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 182 |
|
|
|
| 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%. | The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 266 |
|
|
|
| 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%. | The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 364 |
|
|
|
| 1 |
| 40 |
| 5 |
| 40 |
| EG001 | 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. | 5 | 234 | 47 | 234 |
| Tachycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Retinal Detachment | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Pituitary Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Spinal cord and nerve root disorders | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Upper respiratory tract infections | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Cell marker procedures | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Headaches NEC | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |