Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Study Overview
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Brief Summary
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This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

Detailed Description
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Primary Objective: The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it to that of the active control, Androderm®. Secondary Objective: To establish a safety profile for Nasobol.

Official Title
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Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: Nasobol®
* Drug: Androderm® (Positive Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels >100 ng/dl and ≤ 300 ng/dL. Normal Otolaryngological nasal endoscopy examination. Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL. Exclusion Criteria: Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery. History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test 8.0, Ref 5.0, Test 14.0, Test 11.0<br>Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; | Drug: Nasobol®<br>* Intra-nasal Testosterone (2 syringes), b.i.d.<br>Drug: Androderm® (Positive Control)<br>* QD administration<br>|
| Experimental: Test 11.0, Test 8.0, Ref 5.0, Test 14.0<br>Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days | Drug: Nasobol®<br>* Intra-nasal Testosterone (2 syringes), b.i.d.<br>Drug: Androderm® (Positive Control)<br>* QD administration<br>|
| Experimental: Test 14.0, Test 11.0, Test 8.0, Ref 5.0<br>Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; | Drug: Nasobol®<br>* Intra-nasal Testosterone (2 syringes), b.i.d.<br>Drug: Androderm® (Positive Control)<br>* QD administration<br>|
| Experimental: Ref 5.0, Test 14.0, Test 11.0, Test 8.0<br>Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days | Drug: Nasobol®<br>* Intra-nasal Testosterone (2 syringes), b.i.d.<br>Drug: Androderm® (Positive Control)<br>* QD administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Testosterone Ln-Cmax | The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®. | 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. | 
| Serum Testosterone Ln-AUCt |  | 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. | 
| Serum Testosterone Cavg |  | 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. | 
| Serum Dihydrotestosterone Ln-Cmax |  | 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. | 
| Serum Dihydrotestosterone Ln-AUCt |  | 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. | 
| Serum Dihydrotestosterone Cavg |  | 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. | 
| Percentage of Subjects With Cavg Within the Reference Range | The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone. | Each period is 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Hypogonadism, Secondary Hypogonadism