Efficacy and Tolerability of an Intra-Nasal Testosterone Product

Acerus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypogonadism

Treatments: Drug: Nasobol®; Drug: Androderm® (Positive Control)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975650

TBS1-01

Nasobol-01-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

57 participants in 4 patient groups

Test 8.0, Ref 5.0, Test 14.0, Test 11.0

Experimental group

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:

Drug: Nasobol®

Drug: Androderm® (Positive Control)

Test 11.0, Test 8.0, Ref 5.0, Test 14.0

Experimental group

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

Treatment:

Drug: Nasobol®

Drug: Androderm® (Positive Control)

Test 14.0, Test 11.0, Test 8.0, Ref 5.0

Experimental group

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;

Treatment:

Drug: Nasobol®

Drug: Androderm® (Positive Control)

Ref 5.0, Test 14.0, Test 11.0, Test 8.0

Experimental group

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

Treatment:

Drug: Nasobol®

Drug: Androderm® (Positive Control)