Efficacy of an Intranasal Testosterone Product

This study has been completed.
Information provided by:
Trimel Biopharma SRL
ClinicalTrials.gov Identifier:
First received: December 1, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Condition Intervention Phase
Drug: Testosterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

Resource links provided by NLM:

Further study details as provided by Trimel Biopharma SRL:

Primary Outcome Measures:
  • Pharmacokinetic profile of serum testosterone [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5.0 mg Testosterone t.i.d. Drug: Testosterone
Experimental: 6.75 mg Testosterone b.i.d. Drug: Testosterone
Experimental: 5.625 mg Testosterone t.i.d. Drug: Testosterone


Ages Eligible for Study:   18 Years to 80 Years
Genders 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01252745

United States, Arizona
Quality of Life Medical and Research Center
Tuscon, Arizona, United States
United States, Florida
Pharmax Research Clinic Inc.
Miami, Florida, United States
United States, Louisiana
Regional Urology LLC
Sherveport, Louisiana, United States
Sponsors and Collaborators
Trimel Biopharma SRL
  More Information

Responsible Party: Len Rosenberg, Trimel BioPharma
ClinicalTrials.gov Identifier: NCT01252745     History of Changes
Other Study ID Numbers: TBS-1-2010-01 
Study First Received: December 1, 2010
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 25, 2016