Efficacy of an Intranasal Testosterone Product

Acerus Pharmaceuticals Corporation22 enrolled

Overview

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadism

Interventions

10.0 mg of Testosterone, 4.0% TIDDRUG

13.5 mg of Testosterone, 4.5% B.I.DDRUG

11.25 mg of Testosterone, 4.5% T.I.DDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Quality of Life Medical and Research Center

Tucson, Arizona, United States

Pharmax Research Clinic Inc.

Miami, Florida, United States

Regional Urology LLC

Shreveport, Louisiana, United States

Outcomes

Primary Outcomes

Cmax of Serum Testosterone

Time frame: 24 hours

Cavg of Serum Testosterone

Time frame: 24 hours

AUC0-t of Serum Testosterone

Time frame: 24 hours

Data from ClinicalTrials.gov

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