- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398580
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
May 25, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Torrance, California, United States, 90502
- GSK Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40202
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21287
- GSK Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27710
- GSK Investigational Site
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Texas
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San Antonio, Texas, United States, 78229
- GSK Investigational Site
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Washington
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Seattle, Washington, United States, 98195
- GSK Investigational Site
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Seattle, Washington, United States, 98108
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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days 1 and 28
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Testosterone concentration .
Time Frame: on days 1 and 28
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on days 1 and 28
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Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Time Frame: days 1 and 28.
|
days 1 and 28.
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Anabolic & androgenic Pharmacodynamic biomarkers
Time Frame: pre- and post-dose
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pre- and post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: GSK Clinical Trials, M.D., Ph.D., FACP, GlaxoSmithKline
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
November 8, 2006
First Submitted That Met QC Criteria
November 8, 2006
First Posted (Estimate)
November 10, 2006
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Eunuchism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Androgens
- 5-alpha Reductase Inhibitors
- Anabolic Agents
- Testosterone
- Dutasteride
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- TDC106220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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