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

September 7, 2017 updated by: Endo Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
531

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421
        • Indevus Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
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
Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
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
Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
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
Day 70 post injection at week 14
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.
Days 0, 4, 7, 11, 42, and 70 post injection at week 24
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
Days 0, 4, 7, 11, 42, and 70 post injection at week 24
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
Days 0, 4, 7, 11, 42, and 70 post injection at week 24
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
Day 70 post injection at week 24
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.
Days 0, 4, 7, 11, 14, and 70 post injection at week 4
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
Days 0, 4, 7, 11, 14, and 70 post injection at week 4
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
Days 0, 4, 7, 11, 14, and 70 post injection at week 4
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
Day 70 post injection at week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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.
Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
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
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
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
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
Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14
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
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.
Days 0, 4, 7, 11, 42, and 70 post injection at week 24
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
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
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
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
Days 0, 4, 7, 11, 42, and 70 post injection at week 24
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
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).
Day 21 post injection at week 14
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)
Baseline, Week 24
Change in Weight From Baseline to Week 24 in Part C
Time Frame: Baseline, Week 24
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
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
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
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)
Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44
Trough Assessments of Serum Total Testosterone Concentrations in Part C2
Time Frame: Screening; day 0; and weeks 4, 14, 24, 34, and 44
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
Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endo Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Indevus Pharmaceuticals, Inc., Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IP157-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings