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An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Primary Purpose

Secondary Hypogonadism

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Androxal
Sponsored by
Repros Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hypogonadism

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Androxal

    Arm Description

    Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.

    Outcomes

    Primary Outcome Measures

    Testosterone levels
    Values of total morning testosterone levels at each visit

    Secondary Outcome Measures

    Follicle Stimulating Hormone and Leutinizing Hormone
    Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
    Diabetic Parameters
    Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes
    Change in weight and body mass index (BMI)
    Change in weight and BMI

    Full Information

    First Posted
    November 29, 2012
    Last Updated
    April 15, 2014
    Sponsor
    Repros Therapeutics Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01739582
    Brief Title
    An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
    Official Title
    An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Repros Therapeutics Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine the safety profile of Androxal in men with secondary hypogonadism.
    Detailed Description
    This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Androxal
    Arm Type
    Experimental
    Arm Description
    Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.
    Intervention Type
    Drug
    Intervention Name(s)
    Androxal
    Other Intervention Name(s)
    enclomiphene citrate
    Primary Outcome Measure Information:
    Title
    Testosterone levels
    Description
    Values of total morning testosterone levels at each visit
    Time Frame
    26 weeks
    Secondary Outcome Measure Information:
    Title
    Follicle Stimulating Hormone and Leutinizing Hormone
    Description
    Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit
    Time Frame
    26 weeks
    Title
    Diabetic Parameters
    Description
    Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes
    Time Frame
    26 weeks
    Title
    Change in weight and body mass index (BMI)
    Description
    Change in weight and BMI
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Successful completion of either ZA-301 or ZA-302 Exclusion Criteria: • Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

    12. IPD Sharing Statement

    Links:
    URL
    http://reprosrx.com
    Description
    Sponsor corporate web page

    Learn more about this trial

    An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

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