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Efficacy and Tolerability of an Intra-Nasal Testosterone Product

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975650
First Posted: September 11, 2009
Last Update Posted: August 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Acerus Pharmaceuticals Corporation
  Purpose
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.

Condition Intervention Phase
Hypogonadism Drug: Nasobol® (Intra-nasal Testosterone) Drug: Androderm® (Positive Control) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Resource links provided by NLM:


Further study details as provided by Acerus Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Pharmacokinetic profiles of serum testosterone for subjects dosed at three dosage levels [ Time Frame: 7 days ]

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 8.0 mg Testosterone Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Experimental: 11.0mg Testosterone Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Experimental: 14.0mg Testosterone Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Active Comparator: 5mg Androderm Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Drug: Androderm® (Positive Control)
QD administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975650


Locations
United States, Arizona
Quality of Life Medical & Research centre
Tuscon, Arizona, United States, 85712
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
United States, Florida
Cetero Research
Miami Gardens, Florida, United States, 33169
United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67221
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Texas
dgd Research Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Acerus Pharmaceuticals Corporation
Investigators
Study Director: Paul Desjardins, Ph.D Trimel Biopharma
  More Information

Responsible Party: Dr. Paul Desjardins, Study Director, Trimel Biopharma
ClinicalTrials.gov Identifier: NCT00975650     History of Changes
Other Study ID Numbers: Nasobol-01-2009
TBS1-01
First Submitted: September 10, 2009
First Posted: September 11, 2009
Last Update Posted: August 9, 2010
Last Verified: August 2010

Keywords provided by Acerus Pharmaceuticals Corporation:
Primary Hypogonadism
Secondary Hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents