Last updated: 11/04/2018 12:48:01

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

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GSK study ID
TDC106220
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Clinicaltrials.gov ID
NCT00398580
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EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Average serum testosterone concentration over 24 hour (h) for each treatment arm on Day 28

Timeframe: Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

The percentage of participants classified as responders (24-hr C average (Cavg) within normal limits) for each treatment arm on Day 28. .

Timeframe: Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Number of participants with Adverse events (AE) and serious adverse events (SAE)

Timeframe: Up to 28 days (Visit 10)

Change from baseline in vital signs (heart rate)

Timeframe: Baseline (Day 1, pre -dose), Day 1 (24 h) and Visit 10 (Day 28, 24 h)

Changes from baseline in systolic and diastolic blood pressure (SBP and DBP)

Timeframe: Baseline (Day 1, pre -dose), Day 1 (24 h) and Visit 10 (Day 28, 24 h)

Participants with 12-lead electrocardiogram (ECG) values outside the normal range of potential clinical importance (PCI)

Timeframe: Up to Visit 10

Participants with hematology values outside the normal range PCI

Timeframe: Up to Visit 10 (Follow up)

Participants with clinical chemistry values outside the normal range (PCI)

Timeframe: Up to Visit 10

Secondary outcomes:

Area under curve (AUC) for T, Dihydrotestosterone (DHT), as appropriate: AUC (0-12h), AUC (12-24h), AUC (0-24h) on Day 1 and 28

Timeframe: Day 1 and 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Pharmacokinetic parameters for D as AUC(0-12h), AUC(12-24h), AUC(0-24h) on Day 1 and Day 28

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Maximum observed plasma drug concentration (Cmax) for T and DHT on Day 1 and Day 28

Timeframe: Day 1 and 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Cmax for D on Day 1 and Day 28

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

AUC for estradiol and estrone as appropriate: AUC(0-12h), AUC(12-24h), AUC(0-24h) on Day 1 and Day 28

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Cmax for estradiol and estrone on Day 1 and Day 28.

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Time at which Cmax was observed (Tmax) for T, DHT, estradiol and estrone

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Tmax for D on Day 1 and 28

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

The percentage of participants classified as responders (24-h Cavg within normal limits) for each treatment arm on Day 1

Timeframe: Day 1 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Average serum T concentration over 24 h for each treatment arm on Day 1.

Timeframe: Day 1 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

DHT and DHT/T ratio AUC (0-24h) on Day 1 and Day 28

Timeframe: Day 1 and Day 28 (pre-dose, 0.5 h, 1 h ,2 h,4 h,6 h,8 h,10 h,12 h,12.5 h,13 h,14 h,16 h,18 h,20 h,22 h,24 h)

Pre-dose concentrations of T immediately prior to morning dosing on Day 28

Timeframe: Day 28 (pre-dose)

Pre-dose concentrations of D immediately prior to morning dosing on Day 28

Timeframe: Day 28

Number of participants with prostate specific antigen (PSA), or markers of anabolic effects on skeletal muscle.

Timeframe: Visit 5 (Day -1) and Visit 9 (Day 28)

Number of participants with androgenic Pharmacodynamic biomarkers

Timeframe: Up to Visit 10 (at Visit 5 and Visit 9)

Interventions:
  • Drug: Nanomilled testosterone
  • Drug: Nanomilled dutasteride
  • Drug: commercially available dutasteride
    • Enrollment:
    35
    Primary completion date:
    2007-08-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hypogonadism, Male
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to October 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Have a diagnosis of primary or secondary hypogonadism.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90502
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21287
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    seattle, Washington, United States, 98195
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-08-10
    Actual study completion date
    2007-08-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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