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Trial record 52 of 117 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00398580
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 8, 2006
First Posted Date  ICMJE November 10, 2006
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE October 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine [ Time Frame: days 1 and 28 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Safety measured by: monitoring laboratory tests
  • changes in blood pressure and heart rate
  • and heart activity on an ECG machine days 1 and 28.
Change History Complete list of historical versions of study NCT00398580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
  • Testosterone concentration . [ Time Frame: on days 1 and 28 ]
  • Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride [ Time Frame: days 1 and 28. ]
  • Anabolic & androgenic Pharmacodynamic biomarkers [ Time Frame: pre- and post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Testosterone concentration on days 1 and 28
  • Pharmacokinetics of testosterone, DHT, estradiol, estrone and dutasteride days 1 & 28.
  • Anabolic and androgenic Pharmacodynamic biomarkers pre- and post-dose.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Official Title  ICMJE A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
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 testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypogonadism
  • Hypogonadism, Male
Intervention  ICMJE
  • Drug: Nanomilled testosterone
  • Drug: Nanomilled dutasteride
  • Drug: commercially available dutasteride
    Other Names:
    • Nanomilled testosterone
    • Nanomilled dutasteride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2008)
43
Original Enrollment  ICMJE
 (submitted: November 8, 2006)
100
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00398580
Other Study ID Numbers  ICMJE TDC106220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials, M.D., Ph.D., FACP GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP