Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Conditions
Keywords
investigational, testosterone, testosterone undecanoate, TU, Hypogonadism, primary hypogonadism, secondary hypogonadism
Brief summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
Interventions
DRUGTestosterone Undecanoate 750 mg
DRUGTestosterone Undecanoate 1000 mg
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg) * Morning screening serum testosterone concentration \<300 ng/dL
Exclusion criteria
* American Urological Association (AUA) Symptom Score ≥15 or significant prostatic symptoms * History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof * Screening serum prostate-specific antigen (PSA) level \>4 ng/mL or hyperplasia of the prostate (size \>75 cm3 as measured by transrectal ultrasonography) * Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]) exceeding 1.5 times upper limit of normal * History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident * Severe acne * Hypertension (systolic blood pressure \>160 mm Hg and diastolic blood pressure \>95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator * Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is \>9% * Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug) * Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone \[DHEA\]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug) * Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug * History of sleep apnea Insulin-dependent diabetes mellitus * Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C | Day 70 post injection at week 14 | Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval |
| Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Serum total testosterone Cavg derived from the 4th injection IPK interval |
| Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Serum total testosterone Cmax derived from the 4th injection IPK interval |
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval. |
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval. |
| Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Serum total testosterone Cavg derived from the 3rd injection IPK interval |
| Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval |
| Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C | Day 70 post injection at week 24 | Serum total testosterone Ctrough derived from the 4th injection IPK interval |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL. |
| Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Serum total testosterone Cavg derived from the 2nd injection IPK interval |
| Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | Serum total testosterone Cmax derived from the 2nd injection IPK interval |
| Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2 | Day 70 post injection at week 4 | Serum total testosterone Ctrough derived from the 2nd injection IPK interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL |
| Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | — |
| Serum Total Testosterone Maximum Concentration in Part C2 | Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44 | — |
| Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Day 21 post injection at week 14 | M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied). |
| Change in Body Mass Index From Baseline to Week 24 in Part C | Baseline, Week 24 | Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2) |
| Serum Total Testosterone Maximum Concentration in Part A | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120 | — |
| Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | — |
| Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | — |
| Serum Total Testosterone Concentrations in Part C2 | Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44 | — |
| Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44 | Serum total testosterone concentrations outside the normal range are categorized as \<300 ng/dL (below lower limit of normal range) and \>1000 ng/dL (above upper limit of normal range) |
| Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Screening; day 0; and weeks 4, 14, 24, 34, and 44 | — |
| Change in Weight From Baseline to Week 24 in Part C | Baseline, Week 24 | — |
| Serum Total Testosterone Maximum Concentration in Part B | Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80 | — |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL. |
| Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | — |
| Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | — |
| Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | — |
| Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL |
| Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | — |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL. |
| Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | — |
| Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | — |
| Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | — |
Countries
United States
Participant flow
Pre-assignment details
Of 531 subjects who were enrolled, 524 subjects received study treatment (at least 1 injection). The 7 enrolled subjects who did not receive treatment (2 in Part A and 5 in Part C) were excluded from all analyses.
Participants by arm
| Arm | Count |
|---|---|
| A-TU 750 mg 750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A | 120 |
| A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A | 117 |
| B-TU 750 mg 1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B | 22 |
| B-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B | 112 |
| C-TU 750 mg 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C | 130 |
| C2-TU 750 mg 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 | 23 |
| Total | 524 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 9 | 1 | 15 | 15 | 1 |
| Overall Study | Lost to Follow-up | 5 | 3 | 1 | 1 | 3 | 0 |
| Overall Study | Other/Unknown | 8 | 5 | 1 | 5 | 4 | 0 |
| Overall Study | Protocol Violation | 2 | 1 | 1 | 2 | 0 | 0 |
| Overall Study | Subject Non-compliance | 3 | 4 | 0 | 1 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 14 | 21 | 0 | 9 | 10 | 1 |
Baseline characteristics
| Characteristic | A-TU 750 mg | A-TU 1000 mg | B-TU 750 mg | B-TU 1000 mg | C-TU 750 mg | C2-TU 750 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized | 55.0 years STANDARD_DEVIATION 10.64 | 55.9 years STANDARD_DEVIATION 10.77 | 55.3 years STANDARD_DEVIATION 10.4 | 52.9 years STANDARD_DEVIATION 10.96 | 54.2 years STANDARD_DEVIATION 10.25 | 54.5 years STANDARD_DEVIATION 10.63 | 54.4 years STANDARD_DEVIATION 10.56 |
| Race/Ethnicity, Customized Asian | 2 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Black | 11 participants | 8 participants | 1 participants | 15 participants | 16 participants | 4 participants | 55 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 3 participants | 2 participants | 4 participants | 14 participants | 1 participants | 27 participants |
| Race/Ethnicity, Customized Other | 3 participants | 0 participants | 0 participants | 0 participants | 3 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized White | 101 participants | 106 participants | 18 participants | 92 participants | 97 participants | 18 participants | 432 participants |
| Sex/Gender, Customized Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 120 Participants | 117 Participants | 22 Participants | 112 Participants | 130 Participants | 23 Participants | 524 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 131 / 272 | 120 / 252 |
| serious Total, serious adverse events | 38 / 272 | 37 / 252 |
Outcome results
Primary
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C
Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval.
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C | 94.0 percentage of participants |
Primary
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C
Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval.
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C | 96.2 percentage of participants |
Primary
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2
Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL.
Time frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Cmax ≤1500 ng/dL | 95.7 percentage of participants |
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Cmax 1800-2500 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Cmax >2500 ng/dL | 0 percentage of participants |
Primary
Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
Serum total testosterone Ctrough derived from the 2nd injection IPK interval
Time frame: Day 70 post injection at week 4
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2 | 317.419 ng/dL | Standard Deviation 105.3124 |
Primary
Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2
Serum total testosterone Cavg derived from the 2nd injection IPK interval
Time frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 | 449.6455 ng/dL | Standard Deviation 157.00582 |
Primary
Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C
Serum total testosterone Cavg derived from the 3rd injection IPK interval
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C | 494.9373 ng/dL | Standard Deviation 141.46351 |
Primary
Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C
Serum total testosterone Cavg derived from the 4th injection IPK interval
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C | 514.2792 ng/dL | Standard Deviation 163.11476 |
Primary
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C
Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval
Time frame: Day 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C | 323.522 ng/dL | Standard Deviation 99.1081 |
Primary
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C
Serum total testosterone Ctrough derived from the 4th injection IPK interval
Time frame: Day 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C | 342.800 ng/dL | Standard Deviation 106.918 |
Primary
Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2
Serum total testosterone Cmax derived from the 2nd injection IPK interval
Time frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2 | 689.002 ng/dL | Standard Deviation 266.9442 |
Primary
Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C
Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C | 890.583 ng/dL | Standard Deviation 345.1148 |
Primary
Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C
Serum total testosterone Cmax derived from the 4th injection IPK interval
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C | 837.648 ng/dL | Standard Deviation 412.0692 |
Secondary
Change in Body Mass Index From Baseline to Week 24 in Part C
Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2)
Time frame: Baseline, Week 24
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Change in Body Mass Index From Baseline to Week 24 in Part C | 0.023 kg/m2 | Standard Deviation 0.9543 |
Secondary
Change in Weight From Baseline to Week 24 in Part C
Time frame: Baseline, Week 24
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Change in Weight From Baseline to Week 24 in Part C | 0.06 kg | Standard Deviation 3.009 |
Secondary
Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C
M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied).
Time frame: Day 21 post injection at week 14
Population: Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Confidence or Self-Esteem Improved | 82.6 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Confidence or Self-Esteem No Change | 17.4 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Confidence or Self-Esteem Worsened | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Satisfaction with Sexual Performance Improved | 80.0 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Satisfaction with Sexual Performance No Change | 17.4 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Satisfaction with Sexual Performance Worsened | 2.6 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | General Moods and Behavoir Improved | 80.9 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | General Moods and Behavoir No Change | 19.1 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | General Moods and Behavoir Worsened | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Overal Feeling of Well-Being Improved | 81.7 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Overal Feeling of Well-Being No Change | 18.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Overal Feeling of Well-Being Worsened | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Satisfaction with Study Treatment Satisfied | 92.2 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Satisfaction with Study Treatment No Opinion | 7.8 percentage of participants |
| C-TU 750 mg | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | Satisfaction with Study Treatment Not Satisfied | 0 percentage of participants |
Secondary
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C
Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL.
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C | Cmax ≤1500 ng/dL | 92.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C | Cmax 1800-2500 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C | Cmax >2500 ng/dL | 0 percentage of participants |
Secondary
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C
Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax \>2500 ng/dL.
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C | Cmax ≤1500 ng/dL | 92.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C | Cmax 1800-2500 ng/dL | 3.8 percentage of participants |
| C-TU 750 mg | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C | Cmax >2500 ng/dL | 0 percentage of participants |
Secondary
Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2
Time frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 | Cmax >1000 ng/dL | 8.7 percentage of participants |
| C-TU 750 mg | Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 | Cmax >1100 ng/dL | 4.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 | Cmax >1250 ng/dL | 4.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 | Cmax <300 or >1000 ng/dL | 60.9 percentage of participants |
Secondary
Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C | 51.3 percentage of participants |
Secondary
Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C | 37.5 percentage of participants |
Secondary
Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C | 96.2 percentage of participants |
Secondary
Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C
Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C | 53.8 percentage of participants |
Secondary
Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C
Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C | 62.5 percentage of participants |
Secondary
Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C | 94.9 percentage of participants |
Secondary
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2
Serum total testosterone concentrations outside the normal range are categorized as \<300 ng/dL (below lower limit of normal range) and \>1000 ng/dL (above upper limit of normal range)
Time frame: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Screening, <300 ng/dL | 100.0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Screening, >1000 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 0, <300 ng/dL | 91.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 0, >1000 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 0 at Week 4, <300 ng/dL | 78.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 0 at Week 4, >1000 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 4 post injection at Week 4, <300 ng/dL | 15.0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 4 post injection at Week 4, >1000 ng/dL | 5.0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 7 post injection at Week 4, <300 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 7 post injection at Week 4, >1000 ng/dL | 9.1 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 11 post injection at Week 4, <300 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 11 post injection at Week 4, >1000 ng/dL | 4.5 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 14 post injection at Week 4, <300 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Day 14 post injection at Week 4, >1000 ng/dL | 4.8 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 14, <300 ng/dL | 52.2 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 14, >1000 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 24, <300 ng/dL | 47.8 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 24, >1000 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 34, <300 ng/dL | 36.4 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 34, >1000 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 44, <300 ng/dL | 35.0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Week 44, >1000 ng/dL | 0 percentage of participants |
Secondary
Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C | Cmax >1500-<1800 ng/dL | 7.7 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C | Cmax 1800-2500 ng/dL | 0 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C | Cmax ≤1500 ng/dL | 92.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C | Cmax >2500 ng/dL | 0 percentage of participants |
Secondary
Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C | Cmax ≤1500 ng/dL | 92.3 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C | Cmax >1500 to <1800 ng/dL | 3.8 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C | Cmax 1800 to 2500 ng/dL | 3.8 percentage of participants |
| C-TU 750 mg | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C | Cmax >2500 ng/dL | 0 percentage of participants |
Secondary
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
Time frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-TU 750 mg | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Day 0 (n=23) | 180.33 pg/mL | Standard Deviation 111.646 |
| C-TU 750 mg | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Day 4 (n=20) | 301.85 pg/mL | Standard Deviation 188.818 |
| C-TU 750 mg | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Day 7 (n=22) | 322.74 pg/mL | Standard Deviation 197.018 |
| C-TU 750 mg | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Day 11 (n=22) | 332.92 pg/mL | Standard Deviation 210.534 |
| C-TU 750 mg | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Day 14 (n=21) | 324.74 pg/mL | Standard Deviation 191.489 |
| C-TU 750 mg | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | Day 70 (n=23) | 230.71 pg/mL | Standard Deviation 113.578 |
Secondary
Serum Total Testosterone Concentrations in Part C2
Time frame: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Week 34 (n=22) | 374.698 ng/dL | Standard Deviation 161.7627 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Screening (n=22) | 197.629 ng/dL | Standard Deviation 75.8138 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Day 0 (n=23) | 210.363 ng/dL | Standard Deviation 81.6797 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Day 0 at Week 4 (n=23) | 254.669 ng/dL | Standard Deviation 112.7259 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Day 4 post injection at Week 4 (n=20) | 578.419 ng/dL | Standard Deviation 304.6675 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Day 7 post injection at Week 4 (n=22) | 606.484 ng/dL | Standard Deviation 266.4847 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Day 11 post injection at Week 4 (n=22) | 580.614 ng/dL | Standard Deviation 244.3727 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Day 14 post injection at week 4 (n=21) | 545.236 ng/dL | Standard Deviation 234.5882 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Week 14 (n=23) | 317.419 ng/dL | Standard Deviation 105.3124 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Week 24 (n=23) | 316.215 ng/dL | Standard Deviation 126.143 |
| C-TU 750 mg | Serum Total Testosterone Concentrations in Part C2 | Week 44 (n=20) | 375.797 ng/dL | Standard Deviation 136.5283 |
Secondary
Serum Total Testosterone Maximum Concentration in Part A
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120
Population: Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (20 from A-TU 750 mg and 11 from A-TU 1000 mg)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Maximum Concentration in Part A | 805.867 ng/dL | Standard Deviation 308.5417 |
| A-TU 1000 mg | Serum Total Testosterone Maximum Concentration in Part A | 1023.591 ng/dL | Standard Deviation 394.3051 |
Secondary
Serum Total Testosterone Maximum Concentration in Part B
Time frame: Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80
Population: Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (2 from B-TU 750 mg and 12 from B-TU 1000 mg)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Maximum Concentration in Part B | 986.364 ng/dL | Standard Deviation 330.4247 |
| A-TU 1000 mg | Serum Total Testosterone Maximum Concentration in Part B | 1047.739 ng/dL | Standard Deviation 571.1648 |
Secondary
Serum Total Testosterone Maximum Concentration in Part C2
Time frame: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Serum Total Testosterone Maximum Concentration in Part C2 | 711.343 ng/dL | Standard Deviation 257.5643 |
Secondary
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
Population: PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations \<300 ng/dL were also excluded from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C | 50.2 days | Standard Deviation 17.41 |
Secondary
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C
Time frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
Population: Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations \<300 ng/dL were also excluded from analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| C-TU 750 mg | Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C | 60.6 days | Standard Deviation 17.51 |
Secondary
Trough Assessments of Serum Total Testosterone Concentrations in Part C2
Time frame: Screening; day 0; and weeks 4, 14, 24, 34, and 44
Population: Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Screening (n=22) | 197.629 ng/dL | Standard Deviation 75.8138 |
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Day 0 (n=23) | 210.363 ng/dL | Standard Deviation 81.6797 |
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Week 4 (n=23) | 254.669 ng/dL | Standard Deviation 112.7529 |
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Week 14 (n=23) | 317.419 ng/dL | Standard Deviation 105.3124 |
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Week 24 (n=23) | 316.215 ng/dL | Standard Deviation 126.143 |
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Week 34 (n=22) | 374.698 ng/dL | Standard Deviation 161.7627 |
| C-TU 750 mg | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | Week 44 (n=20) | 375.797 ng/dL | Standard Deviation 136.5283 |