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CompletedNCT00467870TUUpdated Oct 5, 2017Results posted

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

A Phase 3 interventional study of Testosterone Undecanoate 750 mg and Testosterone Undecanoate 1000 mg in Hypogonadism, Primary Hypogonadism and Secondary Hypogonadism, sponsored by Endo USA Inc., a Keenova Therapeutics Company. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-05.

Sponsored by Endo USA Inc., a Keenova Therapeutics Company (part of Keenova Therapeutics plc) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
531
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.

02

Conditions studied

  • Hypogonadism
  • Primary Hypogonadism
  • Secondary Hypogonadism

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Keywords

  • investigational
  • testosterone
  • testosterone undecanoate
  • TU
  • Hypogonadism
  • primary hypogonadism
  • secondary hypogonadism
03

In context

Hypogonadism

352 studies on the registry are indexed under Hypogonadism; 44 are open to participants now.

This study's enrollment of 531 is above the median of 55 across 265 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Browse Endo USA Inc. studies →All Keenova Therapeutics plc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
531 participants (actual)

Study arms

  • Experimental
    1

    750 mg dose of testosterone undecanoate

    Drug: Testosterone Undecanoate 750 mg

  • Experimental
    2

    1000 mg dose testosterone undecanoate

    Drug: Testosterone Undecanoate 1000 mg

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Change in Weight From Baseline to Week 24 in Part C

    Time frame: Baseline, Week 24

  18. 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

  19. 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

  20. 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

  21. 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

  22. Trough Assessments of Serum Total Testosterone Concentrations in Part C2

    Time frame: Screening; day 0; and weeks 4, 14, 24, 34, and 44

  23. 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

07

Results

Posted Mar 7, 2017

Participant flow

Participant flow — Overall Study
MilestoneA-TU 750 mgA-TU 1000 mgB-TU 750 mgB-TU 1000 mgC-TU 750 mgC2-TU 750 mg
Started1201172211213023
Completed757418799321
Not completed4543433372
Withdrew: Adverse event139115151
Withdrew: Protocol violation211200
Withdrew: Withdrawal by subject142109101
Withdrew: Lost to follow-up531130
Withdrew: Subject non-compliance340150
Withdrew: Other/unknown851540

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C
percentage of participantsC-TU 750 mg
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C94.0 (89.7 to 98.3)
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C
ng/dLC-TU 750 mg
Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C494.9373 ± 141.46351
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C
ng/dLC-TU 750 mg
Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C890.583 ± 345.1148
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C
ng/dLC-TU 750 mg
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C323.522 ± 99.1081
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C
percentage of participantsC-TU 750 mg
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C96.2 (92.5 to 99.8)
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C
ng/dLC-TU 750 mg
Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C514.2792 ± 163.11476
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C
ng/dLC-TU 750 mg
Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C837.648 ± 412.0692
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C
ng/dLC-TU 750 mg
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C342.800 ± 106.9180
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2
percentage of participantsC2-TU 750 mg
Cmax ≤1500 ng/dL95.7
Cmax 1800-2500 ng/dL0
Cmax >2500 ng/dL0
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2
ng/dLC2-TU 750 mg
Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2449.6455 ± 157.00582
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2
ng/dLC2-TU 750 mg
Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2689.002 ± 266.9442
PrimarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
ng/dLC2-TU 750 mg
Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2317.419 ± 105.3124
SecondarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Maximum Concentration in Part A
ng/dLA-TU 750 mgA-TU 1000 mg
Serum Total Testosterone Maximum Concentration in Part A805.867 ± 308.54171023.591 ± 394.3051
SecondarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Maximum Concentration in Part B
ng/dLB-TU 750 mgB-TU 1000 mg
Serum Total Testosterone Maximum Concentration in Part B986.364 ± 330.42471047.739 ± 571.1648
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C
percentage of participantsC-TU 750 mg
Cmax ≤1500 ng/dL92.3 (87.5 to 97.1)
Cmax 1800-2500 ng/dL0 (0 to 0)
Cmax >2500 ng/dL0 (0 to 0)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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
percentage of participantsC-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 C51.3 (42.2 to 60.3)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C
percentage of participantsC-TU 750 mg
Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C94.9 (90.9 to 98.9)
SecondaryTime 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
Reported as:
Mean · days
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C
daysC-TU 750 mg
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C50.2 ± 17.41
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C
percentage of participantsC-TU 750 mg
Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C53.8 (44.8 to 62.9)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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
percentage of participantsC-TU 750 mg
Cmax ≤1500 ng/dL92.3 (87.5 to 97.1)
Cmax >1500-<1800 ng/dL7.7 (2.9 to 12.5)
Cmax 1800-2500 ng/dL0 (0 to 0)
Cmax >2500 ng/dL0 (0 to 0)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C
percentage of participantsC-TU 750 mg
Cmax ≤1500 ng/dL92.3 (87.2 to 97.4)
Cmax 1800-2500 ng/dL3.8 (0.2 to 7.5)
Cmax >2500 ng/dL0 (0 to 0)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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
percentage of participantsC-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 C37.5 (28.2 to 46.8)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C
percentage of participantsC-TU 750 mg
Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C96.2 (92.5 to 99.8)
SecondaryTime 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
Reported as:
Mean · days
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C
daysC-TU 750 mg
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C60.6 ± 17.51
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C
percentage of participantsC-TU 750 mg
Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C62.5 (53.2 to 71.8)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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
percentage of participantsC-TU 750 mg
Cmax ≤1500 ng/dL92.3 (87.2 to 97.4)
Cmax >1500 to <1800 ng/dL3.8 (0.2 to 7.5)
Cmax 1800 to 2500 ng/dL3.8 (0.2 to 7.5)
Cmax >2500 ng/dL0 (0 to 0)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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
percentage of participantsC-TU 750 mg
Confidence or Self-Esteem Improved82.6 (75.0 to 90.2)
Confidence or Self-Esteem No Change17.4 (0.8 to 34.0)
Confidence or Self-Esteem Worsened0 (0 to 0)
Satisfaction with Sexual Performance Improved80.0 (71.8 to 88.2)
Satisfaction with Sexual Performance No Change17.4 (0.8 to 34.0)
Satisfaction with Sexual Performance Worsened2.6 (0.0 to 20.6)
General Moods and Behavoir Improved80.9 (72.9 to 88.9)
General Moods and Behavoir No Change19.1 (2.7 to 35.6)
General Moods and Behavoir Worsened0 (0 to 0)
Overal Feeling of Well-Being Improved81.7 (73.9 to 89.5)
Overal Feeling of Well-Being No Change18.3 (1.7 to 34.8)
Overal Feeling of Well-Being Worsened0 (0 to 0)
Satisfaction with Study Treatment Satisfied92.2 (87.1 to 97.3)
Satisfaction with Study Treatment No Opinion7.8 (0.0 to 25.4)
Satisfaction with Study Treatment Not Satisfied0 (0 to 0)
SecondaryChange 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
Reported as:
Mean · kg/m2
Change in Body Mass Index From Baseline to Week 24 in Part C
kg/m2C-TU 750 mg
Change in Body Mass Index From Baseline to Week 24 in Part C0.023 ± 0.9543
SecondaryChange in Weight From Baseline to Week 24 in Part C
Time frame:
Baseline, Week 24
Reported as:
Mean · kg
Change in Weight From Baseline to Week 24 in Part C
kgC-TU 750 mg
Change in Weight From Baseline to Week 24 in Part C0.06 ± 3.009
SecondaryPercentage 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
Reported as:
Number · 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
percentage of participantsC2-TU 750 mg
Cmax >1000 ng/dL8.7
Cmax >1100 ng/dL4.3
Cmax >1250 ng/dL4.3
Cmax <300 or >1000 ng/dL60.9
SecondarySerum 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
Reported as:
Mean · pg/mL
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
pg/mLC2-TU 750 mg
Day 0 (n=23)180.33 ± 111.646
Day 4 (n=20)301.85 ± 188.818
Day 7 (n=22)322.74 ± 197.018
Day 11 (n=22)332.92 ± 210.534
Day 14 (n=21)324.74 ± 191.489
Day 70 (n=23)230.71 ± 113.578
SecondarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Concentrations in Part C2
ng/dLC2-TU 750 mg
Screening (n=22)197.629 ± 75.8138
Day 0 (n=23)210.363 ± 81.6797
Day 0 at Week 4 (n=23)254.669 ± 112.7259
Day 4 post injection at Week 4 (n=20)578.419 ± 304.6675
Day 7 post injection at Week 4 (n=22)606.484 ± 266.4847
Day 11 post injection at Week 4 (n=22)580.614 ± 244.3727
Day 14 post injection at week 4 (n=21)545.236 ± 234.5882
Week 14 (n=23)317.419 ± 105.3124
Week 24 (n=23)316.215 ± 126.1430
Week 34 (n=22)374.698 ± 161.7627
Week 44 (n=20)375.797 ± 136.5283
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2
percentage of participantsC2-TU 750 mg
Screening, <300 ng/dL100.0
Screening, >1000 ng/dL0
Day 0, <300 ng/dL91.3
Day 0, >1000 ng/dL0
Day 0 at Week 4, <300 ng/dL78.3
Day 0 at Week 4, >1000 ng/dL0
Day 4 post injection at Week 4, <300 ng/dL15.0
Day 4 post injection at Week 4, >1000 ng/dL5.0
Day 7 post injection at Week 4, <300 ng/dL0
Day 7 post injection at Week 4, >1000 ng/dL9.1
Day 11 post injection at Week 4, <300 ng/dL0
Day 11 post injection at Week 4, >1000 ng/dL4.5
Day 14 post injection at Week 4, <300 ng/dL0
Day 14 post injection at Week 4, >1000 ng/dL4.8
Week 14, <300 ng/dL52.2
Week 14, >1000 ng/dL0
Week 24, <300 ng/dL47.8
Week 24, >1000 ng/dL0
Week 34, <300 ng/dL36.4
Week 34, >1000 ng/dL0
Week 44, <300 ng/dL35.0
Week 44, >1000 ng/dL0
SecondaryTrough Assessments of Serum Total Testosterone Concentrations in Part C2
Time frame:
Screening; day 0; and weeks 4, 14, 24, 34, and 44
Reported as:
Mean · ng/dL
Trough Assessments of Serum Total Testosterone Concentrations in Part C2
ng/dLC2-TU 750 mg
Screening (n=22)197.629 ± 75.8138
Day 0 (n=23)210.363 ± 81.6797
Week 4 (n=23)254.669 ± 112.7529
Week 14 (n=23)317.419 ± 105.3124
Week 24 (n=23)316.215 ± 126.1430
Week 34 (n=22)374.698 ± 161.7627
Week 44 (n=20)375.797 ± 136.5283
SecondarySerum 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
Reported as:
Mean · ng/dL
Serum Total Testosterone Maximum Concentration in Part C2
ng/dLC2-TU 750 mg
Serum Total Testosterone Maximum Concentration in Part C2711.343 ± 257.5643

Adverse events

Collected over Throughout the study (up to 3 years). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TU 750 mg—38/272 (14%)131/272 (48.2%)
TU 1000 mg—37/252 (14.7%)120/252 (47.6%)
Most frequent serious events
Showing 10 of 73
Most frequent serious events
EventTU 750 mgTU 1000 mg
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)4/2723/252
Coronary artery diseaseCardiac disorders1/2723/252
OsteoarthritisMusculoskeletal and connective tissue disorders1/2723/252
ProstatitisReproductive system and breast disorders1/2723/252
Myocardial infarctionCardiac disorders3/2722/252
Spinal column stenosisMusculoskeletal and connective tissue disorders3/2721/252
Non-cardiac chest painGeneral disorders0/2722/252
Urinary tract infectionInfections and infestations1/2722/252
ArthritisMusculoskeletal and connective tissue disorders0/2722/252
Cerebrovascular accidentNervous system disorders1/2722/252
Most frequent other events
Showing 10 of 24
Most frequent other events
EventTU 750 mgTU 1000 mg
Prostatic specific antigen increasedInvestigations20/27210/252
SinusitisInfections and infestations18/27213/252
FatigueGeneral disorders17/2728/252
Upper respiratory tract infectionInfections and infestations15/27215/252
Injection site painGeneral disorders10/27215/252
HypertensionVascular disorders16/27210/252
NasopharyngitisInfections and infestations14/27214/252
ProstatitisReproductive system and breast disorders15/27213/252
Back PainMusculoskeletal and connective tissue disorders13/27210/252
Musculoskelatal painMusculoskeletal and connective tissue disorders6/27212/252

Baseline characteristics

Includes all participants who were enrolled and received at least 1 injection

Age, Customized
Age, Customized(years)A-TU 750 mgA-TU 1000 mgB-TU 750 mgB-TU 1000 mgC-TU 750 mgC2-TU 750 mgTotal
Mean55.0 ± 10.6455.9 ± 10.7755.3 ± 10.4052.9 ± 10.9654.2 ± 10.2554.5 ± 10.6354.4 ± 10.56
Sex/Gender, Customized
Sex/Gender, Customized(Participants)A-TU 750 mgA-TU 1000 mgB-TU 750 mgB-TU 1000 mgC-TU 750 mgC2-TU 750 mgTotal
Female0000000
Male1201172211213023524
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)A-TU 750 mgA-TU 1000 mgB-TU 750 mgB-TU 1000 mgC-TU 750 mgC2-TU 750 mgTotal
White10110618929718432
Asian2011004
Black11811516455
Hispanic332414127
Other3000306
08

Study locations

1 site
  • Indevus Pharmaceuticals, Inc.
    Lexington, Massachusetts 02421, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2006, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2017, 7 years 8 months after primary completion. A results delay was requested in Aug 2012.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2007
First posted
May 1, 2007
Start
Mar 2006
Primary completionActual
Jul 2009
CompletionActual
Jul 2009
Results delay requested
Aug 31, 2012
Results first posted
Mar 7, 2017
Last update
Oct 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00467870
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
Responsible party
Sponsor
First posted
May 1, 2007
Start date
Mar 2006
Primary completion
Jul 2009
Completion
Jul 2009
Results posted
Mar 7, 2017
Last update
Oct 5, 2017

Study contacts

Indevus Pharmaceuticals, Inc.
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Testosterone undecanoate

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