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A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Testosterone
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

    • Single serum total testosterone concentration < 250 ng/dL, or
    • Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).
  • Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    2% testosterone gel

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
    Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL

    Secondary Outcome Measures

    Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
    Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL

    Full Information

    First Posted
    August 28, 2007
    Last Updated
    September 7, 2017
    Sponsor
    Endo Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00522431
    Brief Title
    A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
    Official Title
    An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Endo Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms. The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    149 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    2% testosterone gel
    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone
    Other Intervention Name(s)
    Fortigel
    Intervention Description
    2% gel
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
    Description
    Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
    Time Frame
    0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
    Description
    Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL
    Time Frame
    0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by: Single serum total testosterone concentration < 250 ng/dL, or Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period). Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liz Waldie
    Organizational Affiliation
    Strakan Pharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

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