Efficacy of an Intranasal Testosterone Product

Hypogonadism Clinical Trial

Official title:

An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252745
• Other study ID #: TBS-1-2010-01
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2018
• Source: Acerus Pharmaceuticals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• 10.0 mg of Testosterone, 4.0% TID

• 13.5 mg of Testosterone, 4.5% B.I.D

• 11.25 mg of Testosterone, 4.5% T.I.D

Locations

Country	Name	City	State
United States	Pharmax Research Clinic Inc.	Miami	Florida
United States	Regional Urology LLC	Shreveport	Louisiana
United States	Quality of Life Medical and Research Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Acerus Pharmaceuticals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Serum Testosterone		24 hours
Primary	Cavg of Serum Testosterone		24 hours
Primary	AUC0-t of Serum Testosterone		24 hours