search
Back to results

Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

Primary Purpose

Hypogonadism, Androgens

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oral testosterone undecanoate (Andriol)
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects were at least 50 years of age
  • A body mass index (BMI) between 18 and 34 kg/m^2
  • Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
  • Calculated free testosterone measurement of <0.26 nmol/L in the morning

Exclusion Criteria:

  • History or current diagnosis of breast or prostate cancer
  • any clinically significant abnormal finding on physical examination including the prostate
  • Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14)
  • Prostate specific antigen (PSA) level > 4 ng/mL at screening
  • Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
  • Hyperprolactinaemia or treatment with prolactin-lowering drugs
  • History of known chronic polycythemia and/or hematocrit >50% at screening
  • History or presence of severe sleep apnea
  • Unstable or untreated endocrine disorders
  • History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
  • Use of medication that would interfere with the efficacy and safety objectives of the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Oral testosterone undecanoate (Andriol)

    Placebo

    Outcomes

    Primary Outcome Measures

    Change from baseline on the total score of the AMS rating scale

    Secondary Outcome Measures

    Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids

    Full Information

    First Posted
    February 12, 2007
    Last Updated
    April 15, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00434824
    Brief Title
    Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)
    Official Title
    A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    July 2004 (Actual)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone. Specifically, we have studied the effects on: symptoms suggestive of low testosterone levels blood testosterone and other hormone levels bone mass muscle mass and fat mass muscle strength prostate lipids, hematocrit

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    322 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Active Comparator
    Arm Description
    Oral testosterone undecanoate (Andriol)
    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Oral testosterone undecanoate (Andriol)
    Other Intervention Name(s)
    Org 538
    Intervention Description
    treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    treatment for 12 months with placebo in divided doses
    Primary Outcome Measure Information:
    Title
    Change from baseline on the total score of the AMS rating scale
    Time Frame
    Month 6
    Secondary Outcome Measure Information:
    Title
    Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids
    Time Frame
    Month 12

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects were at least 50 years of age A body mass index (BMI) between 18 and 34 kg/m^2 Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire) Calculated free testosterone measurement of <0.26 nmol/L in the morning Exclusion Criteria: History or current diagnosis of breast or prostate cancer any clinically significant abnormal finding on physical examination including the prostate Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14) Prostate specific antigen (PSA) level > 4 ng/mL at screening Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism Hyperprolactinaemia or treatment with prolactin-lowering drugs History of known chronic polycythemia and/or hematocrit >50% at screening History or presence of severe sleep apnea Unstable or untreated endocrine disorders History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial Use of medication that would interfere with the efficacy and safety objectives of the trial

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26030346
    Citation
    Meuleman EJ, Legros JJ, Bouloux PM, Johnson-Levonas AO, Kaspers MJ, Elbers JM, Geurts TB, Meehan AG; Study 43203 Investigators. Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism. Aging Male. 2015;18(3):157-63. doi: 10.3109/13685538.2015.1032925. Epub 2015 Jun 1.
    Results Reference
    derived
    PubMed Identifier
    23581697
    Citation
    Bouloux PM, Legros JJ, Elbers JM, Geurts TB, Kaspers MJ, Meehan AG, Meuleman EJ; Study 43203 Investigators. Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year, randomized, placebo-controlled, dose-ranging study. Aging Male. 2013 Jun;16(2):38-47. doi: 10.3109/13685538.2013.773420. Epub 2013 Apr 12.
    Results Reference
    derived

    Learn more about this trial

    Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

    We'll reach out to this number within 24 hrs