Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Conditions
Brief summary
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
Detailed description
Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.
Interventions
DRUGTestosterone undecanoate
Sponsors
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
* Male, age 18-75 * Morning serum testosterone (T) \<300 ng/dL on two occasions * Naive to androgen-replacement therapy or willing to wash-out from current T therapy
Exclusion criteria
* Significant intercurrent disease * Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer. * Serum transaminases \>2 times upper limit of normal * Serum bilirubin \>2.0 mg/dL * Hematocrit \<35% or \>50% * BMI \>36 * Untreated, obstructive sleep apnea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum T Concentration at Steady State | pre-dose on Days 1, 3, 5, 6, and 7 | Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment. |
| Serum T Concentration at Steady-State | pre-dose on Days 10, 14, 17, 21, 24, 27, and 28 | Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Undecanoate Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
Testosterone undecanoate: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Testosterone Undecanoate |
|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 10.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 6 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Serum T Concentration at Steady State
Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.
Time frame: pre-dose on Days 1, 3, 5, 6, and 7
Population: All participants were included in the analysis population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Undecanoate | Serum T Concentration at Steady State | -4.077 ng/dL | Standard Error 16.02 |
p-value: 0.806Regression, Linear
Primary
Serum T Concentration at Steady-State
Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment.
Time frame: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
Population: All participants were included in the analysis population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Undecanoate | Serum T Concentration at Steady-State | 4.114 ng/dL | Standard Error 18.456 |
p-value: 0.8286Regression, Linear