Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Acerus Pharmaceuticals Corporation57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism

Interventions

Nasobol®DRUG

Intra-nasal Testosterone (2 syringes), b.i.d.

Androderm® (Positive Control)DRUG

QD administration

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (6)

Quality of Life Medical & Research centre

Tucson, Arizona, United States

Providence Clinical Research

Burbank, California, United States

Cetero Research

Miami Gardens, Florida, United States

Clinical Research Institute

Wichita, Kansas, United States

Outcomes

Primary Outcomes

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®.