Male Hypogonadism
Conditions
Keywords
testosterone, male hypogonadism, low testosterone
Brief summary
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
Interventions
Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
Sponsors
inVentiv Health Clinical
Clarus Therapeutics, Inc.
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
* Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
Exclusion criteria
* Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression. * Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event * Untreated, severe obstructive sleep apnea * Hematocrit \<35% or \>48% * Serum transaminases \>2 times upper limit of normal, serum bilirubin \>2.0 mg/dL, and serum creatinine \>2.0 mg/dL * BMI \> or equal to 38 * Stable doses of lipid-lowering medication for less than three months * Stable doses of oral medication for diabetes for less than two months * Abnormal prostate digital rectal examination \[palpable nodule(s)\], elevated PSA (serum PSA \>3.9 ng/mL), IPSS score \> or equal to 19 points, and /or history of prostate cancer. * History of breast cancer * Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks * Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors * Known history of abuse of alcohol or any drug substance with the previous 2 years * Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics * Receipt of any drug as part of a research study within 30 days of initial dose administration in this study * Blood donation within the 12 week period before initial dose administration in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114 | The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114 | The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Testosterone Undecanoate Oral testosterone undecanoate: Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments. | 144 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Ca elevated 10.6 | 1 |
| Overall Study | Hematocrit >54% | 3 |
| Overall Study | lack of venous access | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Non-compliance with study drug | 2 |
| Overall Study | Out of country unable to finish study | 1 |
| Overall Study | prohibited med | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 8 |
| Overall Study | work conflict | 1 |
Baseline characteristics
| Characteristic | Oral Testosterone Undecanoate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 28 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants |
| Age, Continuous | 54.8 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 13 Participants |
| Race/Ethnicity, Customized Race Black or African American | 15 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 114 Participants |
| Region of Enrollment United States | 144 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 144 |
| other Total, other adverse events | 46 / 144 |
| serious Total, serious adverse events | 2 / 144 |
Outcome results
Primary
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Population: The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Testosterone Undecanoate | Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL | 87 Participants |
Secondary
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Population: The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Testosterone Undecanoate | Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population | Cmax less that 1500 ng/dL | 95 Participants |
| Oral Testosterone Undecanoate | Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population | Cmax between 1500 and 1800 ng/dL | 10 Participants |
| Oral Testosterone Undecanoate | Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population | Cmax >1800 to 2500 ng/dL | 7 Participants |
| Oral Testosterone Undecanoate | Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population | Cmax >2500 ng/dL | 4 Participants |