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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
September 10, 2009
September 11, 2009
August 9, 2010
August 2009
May 2010   (Final data collection date for primary outcome measure)
Pharmacokinetic profiles of serum testosterone for subjects dosed at three dosage levels [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT00975650 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypogonadism
  • Drug: Nasobol® (Intra-nasal Testosterone)
    BID administration
  • Drug: Androderm® (Positive Control)
    QD administration
  • Experimental: 8.0 mg Testosterone
    Intervention: Drug: Nasobol® (Intra-nasal Testosterone)
  • Experimental: 11.0mg Testosterone
    Intervention: Drug: Nasobol® (Intra-nasal Testosterone)
  • Experimental: 14.0mg Testosterone
    Intervention: Drug: Nasobol® (Intra-nasal Testosterone)
  • Active Comparator: 5mg Androderm
    Interventions:
    • Drug: Nasobol® (Intra-nasal Testosterone)
    • Drug: Androderm® (Positive Control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00975650
Nasobol-01-2009
TBS1-01
No
Not Provided
Not Provided
Dr. Paul Desjardins, Study Director, Trimel Biopharma
Acerus Pharmaceuticals Corporation
Not Provided
Study Director: Paul Desjardins, Ph.D Trimel Biopharma
Acerus Pharmaceuticals Corporation
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP