Efficacy and Tolerability of an Intra-Nasal Testosterone Product

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

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.

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.

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.