Hypogonadism
Conditions
Keywords
Hypogonadism, Testosterone, Hormone replacement therapy
Brief summary
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Detailed description
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.
Interventions
DRUGTesterone Transdermal System
Transdermal testosterone applied daily for 4 weeks
Sponsors
Watson Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males in good general health, 18 years of age or older. * Have a previously documented testosterone deficiency. * Willing and able to comply with the requirements of the protocol.
Exclusion criteria
* Have a history of intolerance to Androderm or other testosterone products. * Prostate specific antigen (PSA) level ≥ 4.0 ng/mL * Prostate cancer or severe benign prostatic hypertrophy (BPH) * Have significant abnormalities in the physical examination at screening. * Have current dermatological disease, skin damage or blemishes. * Have participated in an investigational drug study within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours | Day 28/29 | A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not meet inclusion criteria | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Testosterone Transdermal Systems |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age Continuous | 55.1 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: Day 28/29
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Transdermal Systems | Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours | 463 ng/dL | Standard Deviation 122.1 |