Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Phase 2

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Nasobol®; Drug: Androderm® (Positive Control)

• Registration Number: NCT00975650
• Lead Sponsor: Acerus Pharmaceuticals Corporation

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2018-03-09
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-09
• Last Update Submitted: 2018-08-09
• Results First Posted: 2018-08-13
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ref 5.0, Test 14.0, Test 11.0, Test 8.0	Androderm® (Positive Control)	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
Test 8.0, Ref 5.0, Test 14.0, Test 11.0	Androderm® (Positive Control)	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;
Test 14.0, Test 11.0, Test 8.0, Ref 5.0	Androderm® (Positive Control)	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;
Test 8.0, Ref 5.0, Test 14.0, Test 11.0	Nasobol®	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;
Test 14.0, Test 11.0, Test 8.0, Ref 5.0	Nasobol®	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;
Test 11.0, Test 8.0, Ref 5.0, Test 14.0	Nasobol®	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
Test 11.0, Test 8.0, Ref 5.0, Test 14.0	Androderm® (Positive Control)	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
Ref 5.0, Test 14.0, Test 11.0, Test 8.0	Nasobol®	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

Primary Outcome Measures

Name	Time	Method
Serum Testosterone Ln-Cmax	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®.
Serum Testosterone Ln-AUCt	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.
Serum Dihydrotestosterone Cavg	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.
Serum Dihydrotestosterone Ln-Cmax	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.
Serum Testosterone Cavg	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.
Percentage of Subjects With Cavg Within the Reference Range	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.
Serum Dihydrotestosterone Ln-AUCt	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.

Trial Locations

Locations (6)

Regional Urology, LLC; 🇺🇸 Shreveport, Louisiana, United States

Cetero Research; 🇺🇸 Miami Gardens, Florida, United States

dgd Research Inc.; 🇺🇸 San Antonio, Texas, United States

Providence Clinical Research; 🇺🇸 Burbank, California, United States

Clinical Research Institute; 🇺🇸 Wichita, Kansas, United States

Quality of Life Medical & Research centre; 🇺🇸 Tucson, Arizona, United States