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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
  Purpose

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
Hypogonadism
 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252745

Locations
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

No publications provided

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:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 22, 2013