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Testosterone Treatment for Hypogonadal Men

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Testosterone (T) Gel 1.62%
Placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone Deficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Low T males 18 - 80 years of age

Exclusion Criteria:

  • Normal T levels
  • Elevated Prostatic Specific Antigen (PSA)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    T-Gel 1.62%

    Arm Description

    Placebo

    Testosterone (T) gel 1.62%

    Outcomes

    Primary Outcome Measures

    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
    Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results

    Secondary Outcome Measures

    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results
    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results
    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.
    Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
    The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
    Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
    The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.

    Full Information

    First Posted
    February 8, 2007
    Last Updated
    January 15, 2015
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00433199
    Brief Title
    Testosterone Treatment for Hypogonadal Men
    Official Title
    A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    5. Study Description

    Brief Summary
    Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypogonadism
    Keywords
    Hypogonadism, Testosterone Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    274 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    T-Gel 1.62%
    Arm Type
    Experimental
    Arm Description
    Testosterone (T) gel 1.62%
    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone (T) Gel 1.62%
    Intervention Description
    Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo Control
    Primary Outcome Measure Information:
    Title
    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
    Description
    Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results
    Time Frame
    Day 112
    Secondary Outcome Measure Information:
    Title
    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
    Description
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results
    Time Frame
    Day 14
    Title
    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
    Description
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results
    Time Frame
    Day 56
    Title
    Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
    Description
    Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.
    Time Frame
    Day 182
    Title
    Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
    Description
    The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
    Time Frame
    Day 266
    Title
    Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
    Description
    The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
    Time Frame
    Day 364

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Low T males 18 - 80 years of age Exclusion Criteria: Normal T levels Elevated Prostatic Specific Antigen (PSA)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Clinical Director Solvay
    Organizational Affiliation
    Abbott Products
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22321357
    Citation
    Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9.
    Results Reference
    derived

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