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Status:

COMPLETED

28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

Lead Sponsor:

GlaxoSmithKline

Conditions:

Hypogonadism

Hypogonadism, Male

Eligibility:

MALE

18-70 years

Phase:

PHASE2

Brief Summary

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testos...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Have a diagnosis of primary or secondary hypogonadism.
  • Have very low testosterone levels on 2 separate days.
  • Have a BMI within range of 18.5-35kg/m2.
  • Have not taken dutasteride for one year, or finasteride for the past 3 months.
  • Exclusion criteria:
  • Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
  • Are diabetic with an HbA1c \>= 8.
  • Are taking any androgens, such as testosterone, saw palmetto.
  • Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
  • Would donate more than 500 ML of blood over a 2 month period.
  • Physician does not think it is a good idea for you to participate in the trial. - Are unwilling to abstain from alcohol during the study.
  • Have a positive urine drug screen test.
  • Plan to change your smoking habits during the course of the trial.
  • Have Hepatitis C, Hepatitis B, or HIV.
  • Have a lab or EKG abnormality.
  • High or low blood pressure.
  • Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2007

    Estimated Enrollment :

    43 Patients enrolled

    Trial Details

    Trial ID

    NCT00398580

    Start Date

    October 1 2006

    End Date

    October 1 2007

    Last Update

    May 30 2017

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    GSK Investigational Site

    Torrance, California, United States, 90502

    2

    GSK Investigational Site

    Louisville, Kentucky, United States, 40202

    3

    GSK Investigational Site

    Baltimore, Maryland, United States, 21287

    4

    GSK Investigational Site

    Durham, North Carolina, United States, 27710