Efficacy of an Intranasal Testosterone Product

Phase 2

Completed

• Conditions: Hypogonadism
• Interventions: Drug: 13.5 mg of Testosterone, 4.5% B.I.D; Drug: 10.0 mg of Testosterone, 4.0% TID; Drug: 11.25 mg of Testosterone, 4.5% T.I.D

• Registration Number: NCT01252745
• Lead Sponsor: Acerus Pharmaceuticals Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-03
• Results First Submitted: 2018-02-15
• Results First Submitted QC: 2018-03-27
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Results First Posted: 2018-04-26
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
13.5 mg of TBS-1, 4.5% B.I.D	13.5 mg of Testosterone, 4.5% B.I.D	TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
10.0 mg of TBS-1, 4.0% T.I.D.	10.0 mg of Testosterone, 4.0% TID	TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
11.25 mg of TBS-1, 4.5% T.I.D	11.25 mg of Testosterone, 4.5% T.I.D	TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)

Primary Outcome Measures

Name	Time	Method
AUC0-t of Serum Testosterone	24 hours
Cmax of Serum Testosterone	24 hours
Cavg of Serum Testosterone	24 hours

Trial Locations

Locations (3)

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

Pharmax Research Clinic Inc.; 🇺🇸 Miami, Florida, United States

Quality of Life Medical and Research Center; 🇺🇸 Tucson, Arizona, United States