Hypogonadism
Conditions
Keywords
Hypogonadism
Brief summary
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms. The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.
Interventions
DRUGTestosterone
2% gel
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by: * Single serum total testosterone concentration \< 250 ng/dL, or * Two consecutive serum total testosterone concentrations \< 300 ng/dL (determined at least one week apart during the screening period). * Has a BMI ≥ 22 kg/m2 and \< 35 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 | Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 | Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and \>2500 ng/dL |
Participant flow
Pre-assignment details
Of 406 participants screened, 149 met the inclusion/exclusion criteria and entered the study.
Participants by arm
| Arm | Count |
|---|---|
| Fortigel 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day) | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Other/unknown | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Subject non-compliance | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Fortigel |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 67 / 149 |
| serious Total, serious adverse events | 5 / 149 |
Outcome results
Primary
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Population: Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fortigel | Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | 77.5 percentage of participants |
Secondary
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and \>2500 ng/dL
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Population: Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fortigel | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | ≤1500 ng/dL | 94.6 percentage of participants |
| Fortigel | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | 1800-2500 ng/dL | 1.6 percentage of participants |
| Fortigel | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | >2500 ng/dL | 0 percentage of participants |