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The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone Transdermal Systems | Experimental | Testosterone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testerone Transdermal System | Drug | Transdermal testosterone applied daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours | A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing. | Day 28/29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keshava Kumar, PhD, MHSA | Watson Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson investigational site | Miramar | Florida | 33025 | United States | ||
| Watson investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Transdermal Systems | Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Transdermal Systems | Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours | A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing. | 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. | Posted | Mean | Standard Deviation | ng/dL | Day 28/29 |
|
28 days
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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 | Testosterone Transdermal Systems | Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research | Watson Laboratories, Inc. | 801-588-6641 | gary.hoel@watson.com |
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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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| Omaha |
| Nebraska |
| 68184 |
| United States |
| Watson investigational site | San Antonio | Texas | 78209 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 40 |
| 9 |
| 40 |
| Application site vesicles | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
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| 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 |