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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypogonadism, Hypogonadism, Male

Intervention / Treatment
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* Drug: Nanomilled testosterone
* Drug: Nanomilled dutasteride
* Drug: commercially available dutasteride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nanomilled testosterone|nan|
|Drug: Nanomilled dutasteride|nan|
|Drug: commercially available dutasteride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine |  | days 1 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone concentration . |  | on days 1 and 28 | 
| Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride |  | days 1 and 28. | 
| Anabolic & androgenic Pharmacodynamic biomarkers |  | pre- and post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHT, Testosterone, Hypogonadism, Dutasteride, Androgen deficiency