Efficacy of an Intranasal Testosterone Product

Study Overview
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Brief Summary
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This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Official Title
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An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: 10.0 mg of Testosterone, 4.0% TID
* Drug: 13.5 mg of Testosterone, 4.5% B.I.D
* Drug: 11.25 mg of Testosterone, 4.5% T.I.D


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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10.0 mg of TBS-1, 4.0% T.I.D.<br>TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day) | Drug: 10.0 mg of Testosterone, 4.0% TID<br> <br> * Other names: 10.0 mg of TBS-1, 4.0% TID;|
| Experimental: 13.5 mg of TBS-1, 4.5% B.I.D<br>TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day) | Drug: 13.5 mg of Testosterone, 4.5% B.I.D<br> <br> * Other names: 13.5 mg of TBS-1, 4.5% B.I.D;|
| Experimental: 11.25 mg of TBS-1, 4.5% T.I.D<br>TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day) | Drug: 11.25 mg of Testosterone, 4.5% T.I.D<br> <br> * Other names: 11.25 mg of TBS-1, 4.5% T.I.D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Serum Testosterone |  | 24 hours | 
| Cavg of Serum Testosterone |  | 24 hours | 
| AUC0-t of Serum Testosterone |  | 24 hours |