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Efficacy and Tolerability of an Intra-Nasal Testosterone Product

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ClinicalTrials.gov Identifier: NCT00975650
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypogonadism Drug: Nasobol® Drug: Androderm® (Positive Control) Phase 2

Detailed Description:

Primary Objective:

The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it to that of the active control, Androderm®.

Secondary Objective:

To establish a safety profile for Nasobol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men
Study Start Date : August 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Test 8.0, Ref 5.0, Test 14.0, Test 11.0
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;
 Drug: Nasobol®
Intra-nasal Testosterone (2 syringes), b.i.d.

Drug: Androderm® (Positive Control)
QD administration
Experimental: Test 11.0, Test 8.0, Ref 5.0, Test 14.0
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
 Drug: Nasobol®
Intra-nasal Testosterone (2 syringes), b.i.d.

Drug: Androderm® (Positive Control)
QD administration
Experimental: Test 14.0, Test 11.0, Test 8.0, Ref 5.0
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days;
 Drug: Nasobol®
Intra-nasal Testosterone (2 syringes), b.i.d.

Drug: Androderm® (Positive Control)
QD administration
Experimental: Ref 5.0, Test 14.0, Test 11.0, Test 8.0
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
 Drug: Nasobol®
Intra-nasal Testosterone (2 syringes), b.i.d.

Drug: Androderm® (Positive Control)
QD administration


Outcome Measures
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Primary Outcome Measures :
  1. Serum Testosterone Ln-Cmax [ Time Frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. ]
    The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.

  2. Serum Testosterone Ln-AUCt [ Time Frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. ]
  3. Serum Testosterone Cavg [ Time Frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. ]
  4. Serum Dihydrotestosterone Ln-Cmax [ Time Frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. ]
  5. Serum Dihydrotestosterone Ln-AUCt [ Time Frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. ]
  6. Serum Dihydrotestosterone Cavg [ Time Frame: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours. ]
  7. Percentage of Subjects With Cavg Within the Reference Range [ Time Frame: Each period is 7 days ]
    The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975650


Locations
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United States, Arizona
Quality of Life Medical & Research centre
Tucson, 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
Acerus Pharmaceuticals Corporation
Investigators
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Study Director: Paul Desjardins, Ph.D Trimel Biopharma
More Information
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Responsible Party: Acerus Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00975650    
Other Study ID Numbers: Nasobol-01-2009
TBS1-01
First Posted: September 11, 2009    Key Record Dates
Results First Posted: August 13, 2018
Last Update Posted: August 13, 2018
Last Verified: August 2018
Keywords provided by Acerus Pharmaceuticals Corporation:
Primary Hypogonadism
Secondary Hypogonadism
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs