Hypogonadism
Conditions
Keywords
hypogonadism, testosterone, transdermal system
Brief summary
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
Detailed description
The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).
Interventions
DRUGtestosterone matrix transdermal system
Sponsors
Watson Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male, 18 - 65 years of age; * Documented testosterone deficiency; * BMI 18 to 33.
Exclusion criteria
* Evidence of prostate cancer and benign prostate hyperplasia; * Taking medications that interfere testosterone metabolism; * History of alcohol or drug substance abuse; * Abnormal ECG; * Allergic to transdermal products; * Skin condition that interfere transdermal system application and assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Testosterone Levels in the Normal Range. | Day 29/30 | Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (\>= 300 ng/dL to \<= 1030 ng/dL), at least 85% of subjects with Cmax \<= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax \>= 2500 ng/dL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age Continuous | 49.1 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Percent of Subjects With Testosterone Levels in the Normal Range.
Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (\>= 300 ng/dL to \<= 1030 ng/dL), at least 85% of subjects with Cmax \<= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax \>= 2500 ng/dL.
Time frame: Day 29/30
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Treatment | Percent of Subjects With Testosterone Levels in the Normal Range. | 68.4 percentage of participants | 95% Confidence Interval 132.9 |