Efficacy and Tolerability of an Intra-Nasal Testosterone Product

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. Identifier: NCT00975650
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : August 9, 2010
Information provided by:
Acerus Pharmaceuticals Corporation

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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.

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 identifier (NCT number): NCT00975650

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
Study Director: Paul Desjardins, Ph.D Trimel Biopharma

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

Keywords provided by Acerus Pharmaceuticals Corporation:
Primary Hypogonadism
Secondary Hypogonadism

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