Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975650
• Other study ID #: Nasobol-01-2009
• Secondary ID: TBS1-01
• Status: Completed
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2018
• Source: Acerus Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Nasobol®
Intra-nasal Testosterone (2 syringes), b.i.d.
• Androderm® (Positive Control)
QD administration

Locations

Country	Name	City	State
United States	Providence Clinical Research	Burbank	California
United States	Cetero Research	Miami Gardens	Florida
United States	dgd Research Inc.	San Antonio	Texas
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Quality of Life Medical & Research centre	Tucson	Arizona
United States	Clinical Research Institute	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Acerus Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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