Back to results28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Primary Purpose
Hypogonadism, Hypogonadism, Male
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nanomilled testosterone
Nanomilled dutasteride
commercially available dutasteride
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring DHT, Testosterone, Hypogonadism, Dutasteride, Androgen deficiency
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
Secondary Outcome Measures
Testosterone concentration .
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Anabolic & androgenic Pharmacodynamic biomarkers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00398580
Brief Title
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Hypogonadism, Male
Keywords
DHT, Testosterone, Hypogonadism, Dutasteride, Androgen deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nanomilled testosterone
Intervention Type
Drug
Intervention Name(s)
Nanomilled dutasteride
Intervention Type
Drug
Intervention Name(s)
commercially available dutasteride
Other Intervention Name(s)
Nanomilled testosterone, Nanomilled dutasteride
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Testosterone concentration .
Time Frame
on days 1 and 28
Title
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Time Frame
days 1 and 28.
Title
Anabolic & androgenic Pharmacodynamic biomarkers
Time Frame
pre- and post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, M.D., Ph.D., FACP
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
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28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
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