Efficacy of an Intranasal Testosterone Product

This study has been completed.
Sponsor:
Information provided by:
Trimel Biopharma SRL
ClinicalTrials.gov Identifier:
NCT01252745
First received: December 1, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 1, 2010
December 1, 2010
August 2010
November 2010   (final data collection date for primary outcome measure)
Pharmacokinetic profile of serum testosterone [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
Efficacy of an Intranasal Testosterone Product
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypogonadism
Drug: Testosterone
  • Experimental: 5.0 mg Testosterone t.i.d.
    Intervention: Drug: Testosterone
  • Experimental: 6.75 mg Testosterone b.i.d.
    Intervention: Drug: Testosterone
  • Experimental: 5.625 mg Testosterone t.i.d.
    Intervention: Drug: Testosterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2010
November 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
 
NCT01252745
TBS-1-2010-01
No
Len Rosenberg, Trimel BioPharma
Trimel Biopharma SRL
Not Provided
Not Provided
Trimel Biopharma SRL
December 2010

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