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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypogonadism
 Drug: Nasobol® (Intra-nasal Testosterone)
Drug: Androderm® (Positive Control)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Trimel Biopharma SRL:

Primary Outcome Measures:
  • Pharmacokinetic profiles of serum testosterone for subjects dosed at three dosage levels [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 8.0 mg Testosterone Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Experimental: 11.0mg Testosterone Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Experimental: 14.0mg Testosterone Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Active Comparator: 5mg Androderm Drug: Nasobol® (Intra-nasal Testosterone)
BID administration
Drug: Androderm® (Positive Control)
QD administration

  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: NCT00975650

Locations
United States, Arizona
Quality of Life Medical & Research centre
Tuscon, Arizona, United States, 85712
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
United States, Florida
Cetero Research
Miami Gardens, Florida, United States, 33169
United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67221
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Texas
dgd Research Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Trimel Biopharma SRL
Investigators
Study Director: Paul Desjardins, Ph.D Trimel Biopharma
  More Information

No publications provided

Responsible Party: Dr. Paul Desjardins, Study Director, Trimel Biopharma
ClinicalTrials.gov Identifier: NCT00975650     History of Changes
Other Study ID Numbers: Nasobol-01-2009, TBS1-01
Study First Received: September 10, 2009
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Trimel Biopharma SRL:
Primary Hypogonadism
Secondary Hypogonadism

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 16, 2013