Trial Outcomes & Findings for Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men (NCT NCT00467870)

Last Updated: 2017-10-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

531 participants

Primary outcome timeframe

Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14

Results posted on

2017-10-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	A-TU 750 mg 750 mg testosterone undecanoate (TU) in 3 mL oily solution, intramuscularly (IM) every 12 weeks for up to 3 years in Part A	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A	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	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	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	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
Overall Study STARTED	120	117	22	112	130	23
Overall Study COMPLETED	75	74	18	79	93	21
Overall Study NOT COMPLETED	45	43	4	33	37	2

Reasons for withdrawal

Reasons for withdrawal
Measure	A-TU 750 mg 750 mg testosterone undecanoate (TU) in 3 mL oily solution, intramuscularly (IM) every 12 weeks for up to 3 years in Part A	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A	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	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	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	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
Overall Study Adverse Event	13	9	1	15	15	1
Overall Study Protocol Violation	2	1	1	2	0	0
Overall Study Withdrawal by Subject	14	21	0	9	10	1
Overall Study Lost to Follow-up	5	3	1	1	3	0
Overall Study Subject Non-compliance	3	4	0	1	5	0
Overall Study Other/Unknown	8	5	1	5	4	0

Baseline Characteristics

Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-TU 750 mg n=120 Participants 750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A	A-TU 1000 mg n=117 Participants 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A	B-TU 750 mg n=22 Participants 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	B-TU 1000 mg n=112 Participants 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	C-TU 750 mg n=130 Participants 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	C2-TU 750 mg n=23 Participants 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	Total n=524 Participants Total of all reporting groups
Age, Customized	55.0 years STANDARD_DEVIATION 10.64 • n=5 Participants	55.9 years STANDARD_DEVIATION 10.77 • n=7 Participants	55.3 years STANDARD_DEVIATION 10.40 • n=5 Participants	52.9 years STANDARD_DEVIATION 10.96 • n=4 Participants	54.2 years STANDARD_DEVIATION 10.25 • n=21 Participants	54.5 years STANDARD_DEVIATION 10.63 • n=8 Participants	54.4 years STANDARD_DEVIATION 10.56 • n=8 Participants
Sex/Gender, Customized Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex/Gender, Customized Male	120 Participants n=5 Participants	117 Participants n=7 Participants	22 Participants n=5 Participants	112 Participants n=4 Participants	130 Participants n=21 Participants	23 Participants n=8 Participants	524 Participants n=8 Participants
Race/Ethnicity, Customized White	101 participants n=5 Participants	106 participants n=7 Participants	18 participants n=5 Participants	92 participants n=4 Participants	97 participants n=21 Participants	18 participants n=8 Participants	432 participants n=8 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	4 participants n=8 Participants
Race/Ethnicity, Customized Black	11 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	15 participants n=4 Participants	16 participants n=21 Participants	4 participants n=8 Participants	55 participants n=8 Participants
Race/Ethnicity, Customized Hispanic	3 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	14 participants n=21 Participants	1 participants n=8 Participants	27 participants n=8 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants	0 participants n=8 Participants	6 participants n=8 Participants

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 89.7 to 98.3	—

PRIMARY outcome

Timeframe: 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)

Serum total testosterone Cavg derived from the 3rd injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C	494.9373 ng/dL Standard Deviation 141.46351	—

PRIMARY outcome

Timeframe: 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)

Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C	890.583 ng/dL Standard Deviation 345.1148	—

PRIMARY outcome

Timeframe: 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)

Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 92.5 to 99.8	—

PRIMARY outcome

Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Serum total testosterone Cavg derived from the 4th injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C	514.2792 ng/dL Standard Deviation 163.11476	—

PRIMARY outcome

Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Serum total testosterone Cmax derived from the 4th injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C	837.648 ng/dL Standard Deviation 412.0692	—

PRIMARY outcome

Timeframe: Day 70 post injection at week 24

Serum total testosterone Ctrough derived from the 4th injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C	342.800 ng/dL Standard Deviation 106.9180	—

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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	—
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	—
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 outcome

Timeframe: 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)

Serum total testosterone Cavg derived from the 2nd injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2	449.6455 ng/dL Standard Deviation 157.00582	—

PRIMARY outcome

Timeframe: 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)

Serum total testosterone Cmax derived from the 2nd injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2	689.002 ng/dL Standard Deviation 266.9442	—

PRIMARY outcome

Timeframe: 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)

Serum total testosterone Ctrough derived from the 2nd injection IPK interval

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=106 Participants 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	A-TU 1000 mg n=100 Participants 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Maximum Concentration in Part A	805.867 ng/dL Standard Deviation 308.5417	1023.591 ng/dL Standard Deviation 394.3051

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=20 Participants 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	A-TU 1000 mg n=100 Participants 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Maximum Concentration in Part B	986.364 ng/dL Standard Deviation 330.4247	1047.739 ng/dL Standard Deviation 571.1648

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 87.5 to 97.1	—
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 Interval 0.0 to 0.0	—
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 Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 42.2 to 60.3	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 90.9 to 98.9	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=60 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 outcome

Timeframe: 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)

Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C	53.8 percentage of participants Interval 44.8 to 62.9	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 87.5 to 97.1	—
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 Interval 2.9 to 12.5	—
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 Interval 0.0 to 0.0	—
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 Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 87.2 to 97.4	—
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 Interval 0.2 to 7.5	—
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 Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 28.2 to 46.8	—

SECONDARY outcome

Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 92.5 to 99.8	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=39 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C	62.5 percentage of participants Interval 53.2 to 71.8	—

SECONDARY outcome

Timeframe: Days 0, 4, 7, 11, 42, and 70 post injection at week 24

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=104 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 0.2 to 7.5	—
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 Interval 87.2 to 97.4	—
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 Interval 0.2 to 7.5	—
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 Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=117 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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 Interval 75.0 to 90.2	—
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 Interval 0.8 to 34.0	—
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 Interval 0.0 to 0.0	—
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 Interval 71.8 to 88.2	—
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 Interval 0.8 to 34.0	—
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 Interval 0.0 to 20.6	—
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 Interval 72.9 to 88.9	—
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 Interval 2.7 to 35.6	—
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 Interval 0.0 to 0.0	—
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 Interval 73.9 to 89.5	—
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 Interval 1.7 to 34.8	—
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 Interval 0.0 to 0.0	—
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 Interval 87.1 to 97.3	—
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 Interval 0.0 to 25.4	—
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 Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: 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

Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=116 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Change in Body Mass Index From Baseline to Week 24 in Part C	0.023 kg/m2 Standard Deviation 0.9543	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=116 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Change in Weight From Baseline to Week 24 in Part C	0.06 kg Standard Deviation 3.009	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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	—
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	—
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	—
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 outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 Day 0 (n=23)	180.33 pg/mL Standard Deviation 111.646	—
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 Day 4 (n=20)	301.85 pg/mL Standard Deviation 188.818	—
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 Day 7 (n=22)	322.74 pg/mL Standard Deviation 197.018	—
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 Day 11 (n=22)	332.92 pg/mL Standard Deviation 210.534	—
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 Day 14 (n=21)	324.74 pg/mL Standard Deviation 191.489	—
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 Day 70 (n=23)	230.71 pg/mL Standard Deviation 113.578	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Concentrations in Part C2 Day 14 post injection at week 4 (n=21)	545.236 ng/dL Standard Deviation 234.5882	—
Serum Total Testosterone Concentrations in Part C2 Screening (n=22)	197.629 ng/dL Standard Deviation 75.8138	—
Serum Total Testosterone Concentrations in Part C2 Day 0 (n=23)	210.363 ng/dL Standard Deviation 81.6797	—
Serum Total Testosterone Concentrations in Part C2 Day 0 at Week 4 (n=23)	254.669 ng/dL Standard Deviation 112.7259	—
Serum Total Testosterone Concentrations in Part C2 Day 4 post injection at Week 4 (n=20)	578.419 ng/dL Standard Deviation 304.6675	—
Serum Total Testosterone Concentrations in Part C2 Day 7 post injection at Week 4 (n=22)	606.484 ng/dL Standard Deviation 266.4847	—
Serum Total Testosterone Concentrations in Part C2 Day 11 post injection at Week 4 (n=22)	580.614 ng/dL Standard Deviation 244.3727	—
Serum Total Testosterone Concentrations in Part C2 Week 14 (n=23)	317.419 ng/dL Standard Deviation 105.3124	—
Serum Total Testosterone Concentrations in Part C2 Week 24 (n=23)	316.215 ng/dL Standard Deviation 126.1430	—
Serum Total Testosterone Concentrations in Part C2 Week 34 (n=22)	374.698 ng/dL Standard Deviation 161.7627	—
Serum Total Testosterone Concentrations in Part C2 Week 44 (n=20)	375.797 ng/dL Standard Deviation 136.5283	—

SECONDARY outcome

Timeframe: 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)

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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
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	—
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 Screening, <300 ng/dL	100.0 percentage of participants	—
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 Screening, >1000 ng/dL	0 percentage of participants	—
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	—
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 Day 0, >1000 ng/dL	0 percentage of participants	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 Week 14, >1000 ng/dL	0 percentage of participants	—
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	—
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 Week 24, >1000 ng/dL	0 percentage of participants	—
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	—
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 Week 34, >1000 ng/dL	0 percentage of participants	—
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	—
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 outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Screening (n=22)	197.629 ng/dL Standard Deviation 75.8138	—
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Day 0 (n=23)	210.363 ng/dL Standard Deviation 81.6797	—
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Week 4 (n=23)	254.669 ng/dL Standard Deviation 112.7529	—
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Week 14 (n=23)	317.419 ng/dL Standard Deviation 105.3124	—
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Week 24 (n=23)	316.215 ng/dL Standard Deviation 126.1430	—
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Week 34 (n=22)	374.698 ng/dL Standard Deviation 161.7627	—
Trough Assessments of Serum Total Testosterone Concentrations in Part C2 Week 44 (n=20)	375.797 ng/dL Standard Deviation 136.5283	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	C-TU 750 mg n=23 Participants 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	A-TU 1000 mg 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
Serum Total Testosterone Maximum Concentration in Part C2	711.343 ng/dL Standard Deviation 257.5643	—

Adverse Events

TU 750 mg

Serious events: 38 serious events

Other events: 131 other events

Deaths: 0 deaths

TU 1000 mg

Serious events: 37 serious events

Other events: 120 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Coordinator

Endo Pharmaceuticals Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	TU 750 mg n=272 participants at risk 750 mg TU in 3 mL oily solution, IM at baseline and during the study in Part A, C, or C2 (includes participants from A-750 mg, C-750 mg, and C2-750 mg)	TU 1000 mg n=252 participants at risk 1000 mg TU in 4 mL oily solution, IM at any time during the study in Part A or B (includes participants from A-1000 mg, B-750 mg, and B-1000 mg)
Infections and infestations Sinusitis	6.6% 18/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	5.2% 13/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Infections and infestations Upper respiratory tract infection	5.5% 15/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	6.0% 15/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Infections and infestations Nasopharyngitis	5.1% 14/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	5.6% 14/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Infections and infestations Bronchitis	4.4% 12/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Infections and infestations Urinary tract infection	1.8% 5/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.6% 9/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 12/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.4% 11/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Musculoskeletal and connective tissue disorders Back Pain	4.8% 13/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.0% 10/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Musculoskeletal and connective tissue disorders Musculoskelatal pain	2.2% 6/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.8% 12/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 9/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.6% 9/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Investigations Prostatic specific antigen increased	7.4% 20/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.0% 10/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
General disorders Fatigue	6.2% 17/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
General disorders Injection site pain	3.7% 10/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	6.0% 15/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Reproductive system and breast disorders Prostatitis	5.5% 15/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	5.2% 13/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Reproductive system and breast disorders Erectile dysfunction	1.5% 4/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.0% 10/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Gastrointestinal disorders Diarrhoae	1.5% 4/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.4% 11/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Gastrointestinal disorders Nausea	1.5% 4/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Psychiatric disorders Insomnia	4.4% 12/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.8% 12/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Psychiatric disorders Depression	2.9% 8/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Psychiatric disorders Anxiety	1.8% 5/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Nervous system disorders Headache	2.2% 6/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Renal and urinary disorders Dysuria	1.1% 3/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	3.2% 8/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Skin and subcutaneous tissue disorders Acne	3.3% 9/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	1.6% 4/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	3.7% 10/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	1.6% 4/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study
Vascular disorders Hypertension	5.9% 16/272 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study	4.0% 10/252 • Throughout the study (up to 3 years) Includes all participants who were enrolled and received at least 1 injection, pooled into groups of maximum TU dose received at any time during the study