Efficacy and Tolerability of an Intra-Nasal Testosterone Product

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nasobol®

Androderm® (Positive Control)

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Primary Hypogonadism, Secondary Hypogonadism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Quality of Life Medical & Research centre
Providence Clinical Research
Cetero Research
Clinical Research Institute
Regional Urology, LLC
dgd Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Test 8.0, Ref 5.0, Test 14.0, Test 11.0

Test 11.0, Test 8.0, Ref 5.0, Test 14.0

Test 14.0, Test 11.0, Test 8.0, Ref 5.0

Ref 5.0, Test 14.0, Test 11.0, Test 8.0

Arm Description

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;

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

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;

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

Outcomes

Primary Outcome Measures

Serum Testosterone Ln-Cmax

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®.

Serum Testosterone Ln-AUCt

Serum Testosterone Cavg

Serum Dihydrotestosterone Ln-Cmax

Serum Dihydrotestosterone Ln-AUCt

Serum Dihydrotestosterone Cavg

Percentage of Subjects With Cavg Within the Reference Range

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00975650

First Posted

September 10, 2009

Last Updated

August 9, 2018

Sponsor

Acerus Pharmaceuticals Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00975650

Brief Title

Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Official Title

Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acerus Pharmaceuticals Corporation

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

Primary Hypogonadism, Secondary Hypogonadism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test 8.0, Ref 5.0, Test 14.0, Test 11.0

Arm Type

Experimental

Arm Description

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;

Arm Title

Test 11.0, Test 8.0, Ref 5.0, Test 14.0

Arm Type

Experimental

Arm Description

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

Arm Title

Test 14.0, Test 11.0, Test 8.0, Ref 5.0

Arm Type

Experimental

Arm Description

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;

Arm Title

Ref 5.0, Test 14.0, Test 11.0, Test 8.0

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nasobol®

Intervention Description

Intra-nasal Testosterone (2 syringes), b.i.d.

Intervention Type

Drug

Intervention Name(s)

Androderm® (Positive Control)

Intervention Description

QD administration

Primary Outcome Measure Information:

Title

Serum Testosterone Ln-Cmax

Description

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®.

Time Frame