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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467870
First Posted: May 1, 2007
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endo Pharmaceuticals
  Purpose
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.

Condition Intervention Phase
Hypogonadism Primary Hypogonadism Secondary Hypogonadism Drug: Testosterone Undecanoate 750 mg Drug: Testosterone Undecanoate 1000 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder 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 ]
    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 [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
    Serum total testosterone Cavg derived from the 3rd injection IPK interval

  • Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
    Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval

  • Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C [ Time Frame: Day 70 post injection at week 14 ]
    Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval

  • Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C [ Time Frame: 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.

  • Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
    Serum total testosterone Cavg derived from the 4th injection IPK interval

  • Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
    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 [ Time Frame: Day 70 post injection at week 24 ]
    Serum total testosterone Ctrough derived from the 4th injection IPK interval

  • Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 [ Time Frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4 ]
    Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.

  • Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 [ Time Frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4 ]
    Serum total testosterone Cavg derived from the 2nd injection IPK interval

  • Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2 [ Time Frame: Days 0, 4, 7, 11, 14, and 70 post injection at week 4 ]
    Serum total testosterone Cmax derived from the 2nd injection IPK interval

  • Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2 [ Time Frame: Day 70 post injection at week 4 ]
    Serum total testosterone Ctrough derived from the 2nd injection IPK interval


Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success 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 ]
    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 [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
  • Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
  • Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
  • Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
    Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL

  • Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 ]
  • Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
    Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL.

  • Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
  • Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
  • Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
  • Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
    Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL

  • Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C [ Time Frame: Days 0, 4, 7, 11, 42, and 70 post injection at week 24 ]
  • 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 [ Time Frame: Day 21 post injection at week 14 ]
    M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied).

  • Change in Body Mass Index From Baseline to Week 24 in Part C [ Time Frame: Baseline, Week 24 ]
    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 [ Time Frame: Baseline, Week 24 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range 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 ]
    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 [ Time Frame: Screening; day 0; and weeks 4, 14, 24, 34, and 44 ]
  • 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 ]

Enrollment: 531
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467870


Locations
United States, Massachusetts
Indevus Pharmaceuticals, Inc.
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Indevus Pharmaceuticals, Inc. Sponsor GmbH
  More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00467870     History of Changes
Other Study ID Numbers: IP157-001
First Submitted: April 27, 2007
First Posted: May 1, 2007
Results First Submitted: November 7, 2016
Results First Posted: October 5, 2017
Last Update Posted: October 5, 2017
Last Verified: September 2017

Keywords provided by Endo Pharmaceuticals:
investigational
testosterone
testosterone undecanoate
TU
Hypogonadism
primary hypogonadism
secondary hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents