Back to resultsLong-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men (TU)
Primary Purpose
Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Testosterone Undecanoate 750 mg
Testosterone Undecanoate 1000 mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring investigational, testosterone, testosterone undecanoate, TU, Hypogonadism, primary hypogonadism, secondary hypogonadism
Eligibility Criteria
Inclusion Criteria:
- Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg)
- Morning screening serum testosterone concentration <300 ng/dL
Exclusion Criteria:
- American Urological Association (AUA) Symptom Score ≥15 or significant prostatic symptoms
- History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof
- Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the prostate (size >75 cm3 as measured by transrectal ultrasonography)
- Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) exceeding 1.5 times upper limit of normal
- History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident
- Severe acne
- Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator
- Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is >9%
- Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug)
- Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug)
- Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug
- History of sleep apnea Insulin-dependent diabetes mellitus
- Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)
Sites / Locations
- Indevus Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
750 mg dose of testosterone undecanoate
1000 mg dose testosterone undecanoate
Outcomes
Primary Outcome Measures
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.
Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C
Serum total testosterone Cavg derived from the 3rd injection IPK interval
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
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
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.
Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C
Serum total testosterone Cavg derived from the 4th injection IPK interval
Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C
Serum total testosterone Cmax derived from the 4th injection IPK interval
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
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.
Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2
Serum total testosterone Cavg derived from the 2nd injection IPK interval
Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2
Serum total testosterone Cmax derived from the 2nd injection IPK interval
Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
Serum total testosterone Ctrough derived from the 2nd injection IPK interval
Secondary Outcome Measures
Serum Total Testosterone Maximum Concentration in Part A
Serum Total Testosterone Maximum Concentration in Part B
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.
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 Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C
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
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 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.
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 Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C
Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C
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
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 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).
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)
Change in Weight From Baseline to Week 24 in Part C
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
Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
Serum Total Testosterone Concentrations in Part C2
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)
Trough Assessments of Serum Total Testosterone Concentrations in Part C2
Serum Total Testosterone Maximum Concentration in Part C2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00467870
Brief Title
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Acronym
TU
Official Title
A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Keywords
investigational, testosterone, testosterone undecanoate, TU, Hypogonadism, primary hypogonadism, secondary hypogonadism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
531 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
750 mg dose of testosterone undecanoate
Arm Title
2
Arm Type
Experimental
Arm Description
1000 mg dose testosterone undecanoate
Intervention Type
Drug
Intervention Name(s)
Testosterone Undecanoate 750 mg
Intervention Type
Drug
Intervention Name(s)
Testosterone Undecanoate 1000 mg
Primary Outcome Measure Information:
Title
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C
Description
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
Title
Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C
Description
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
Title
Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C
Description
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
Title
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C
Description
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
Title
Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C
Description
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
Title
Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C
Description
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
Title
Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C
Description
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
Title
Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C
Description
Serum total testosterone Ctrough derived from the 4th injection IPK interval
Time Frame
Day 70 post injection at week 24
Title
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2
Description
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
Title
Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2
Description
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
Title
Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2
Description
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
Title
Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
Description
Serum total testosterone Ctrough derived from the 2nd injection IPK interval
Time Frame
Day 70 post injection at week 4
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C
Description
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
Title
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
Title
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
Title
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
Title
Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C
Description
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
Title
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
Title
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C
Description
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
Title
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
Title
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
Title
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
Title
Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C
Description
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
Title
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
Title
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
Description
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
Title
Change in Body Mass Index From Baseline to Week 24 in Part C
Description
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
Title
Change in Weight From Baseline to Week 24 in Part C
Time Frame
Baseline, Week 24
Title
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
Title
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
Title
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
Title
Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2
Description
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
Title
Trough Assessments of Serum Total Testosterone Concentrations in Part C2
Time Frame
Screening; day 0; and weeks 4, 14, 24, 34, and 44
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male with primary or secondary hypogonadism at least 18 years of age and for study part C2 weighs ≥143.3 lb (≥65 kg)
Morning screening serum testosterone concentration <300 ng/dL
Exclusion Criteria:
American Urological Association (AUA) Symptom Score ≥15 or significant prostatic symptoms
History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof
Screening serum prostate-specific antigen (PSA) level >4 ng/mL or hyperplasia of the prostate (size >75 cm3 as measured by transrectal ultrasonography)
Past or present liver tumors or acute or chronic hepatic disease with impairment of liver function; liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) exceeding 1.5 times upper limit of normal
History of deep vein thrombosis in the past 5 years or any history of cerebrovascular accident
Severe acne
Hypertension (systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg) or coronary heart disease not stabilized by therapy as assessed by the investigator
Insulin-dependent diabetes mellitus or uncontrolled non-insulin-dependent diabetes mellitus; patients with diabetes are excluded if screening glycated hemoglobin (HbA1C) level is >9%
Use of any sex hormones within 28 days (for injectable testosterone preparations) or 7 days (for oral, gel, patch, etc, testosterone preparations) prior to screening visit and throughout the study (exclusive of administered study drug)
Use of steroidal anabolic drugs or supplements (eg, dehydroepiandrosterone [DHEA]) by any application method within the 28 days prior to first administration of study drug and throughout the study (exclusive of administrated study drug)
Medication with substances which might interfere with testosterone metabolism within 28 days before the first administration of study drug
History of sleep apnea Insulin-dependent diabetes mellitus
Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indevus Pharmaceuticals, Inc.
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Indevus Pharmaceuticals, Inc.
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
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