Clinical trial NCT00467870: Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Primary Hypogonadism
Secondary Hypogonadism
Keywords: investigational
testosterone
testosterone undecanoate
TU
Hypogonadism
primary hypogonadism
secondary hypogonadism
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-01
Enrollment: 531
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C
timeFrame: Day 70 post injection at week 14
measure: Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C
timeFrame: Day 70 post injection at week 24
measure: Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2
timeFrame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
measure: Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2
timeFrame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
measure: Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2
timeFrame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
measure: Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2
timeFrame: Day 70 post injection at week 4
Secondary outcomes:
measure: Serum Total Testosterone Maximum Concentration in Part A
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
measure: Serum Total Testosterone Maximum Concentration in Part B
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
measure: Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: 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
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: 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
timeFrame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
measure: Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: 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
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: 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
timeFrame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24
measure: 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
timeFrame: Day 21 post injection at week 14
measure: Change in Body Mass Index From Baseline to Week 24 in Part C
timeFrame: Baseline, Week 24
measure: Change in Weight From Baseline to Week 24 in Part C
timeFrame: Baseline, Week 24
measure: 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
timeFrame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
measure: Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2
timeFrame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4
measure: Serum Total Testosterone Concentrations in Part C2
timeFrame: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44
measure: Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2
timeFrame: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44
measure: Trough Assessments of Serum Total Testosterone Concentrations in Part C2
timeFrame: Screening; day 0; and weeks 4, 14, 24, 34, and 44
measure: Serum Total Testosterone Maximum Concentration in Part C2
timeFrame: Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Indevus Pharmaceuticals, Inc.
state: Massachusetts
Study officials:
affiliation: Sponsor GmbH
name: Indevus Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References: