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Efficacy and Tolerability of an Intra-Nasal Testosterone Product

This study has been completed.
Sponsor:
Information provided by:
Trimel Biopharma SRL
ClinicalTrials.gov Identifier:
NCT00975650
First received: September 10, 2009
Last updated: August 5, 2010
Last verified: August 2010

September 10, 2009
August 5, 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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00975650
Nasobol-01-2009, TBS1-01
No
Dr. Paul Desjardins, Study Director, Trimel Biopharma
Trimel Biopharma SRL
Not Provided
Study Director: Paul Desjardins, Ph.D Trimel Biopharma
Trimel Biopharma SRL
August 2010

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