Efficacy of an Intranasal Testosterone Product

NCT01252745 | Completed Phase 2 Results

• 1 other identifier: TBS-1-2010-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (3)

• Cmax of Serum Testosterone

  24 hours

• Cavg of Serum Testosterone

  24 hours

• AUC0-t of Serum Testosterone

  24 hours

Study Arms (3)

10.0 mg of TBS-1, 4.0% T.I.D.

EXPERIMENTAL

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)

Drug: 10.0 mg of Testosterone, 4.0% TID

13.5 mg of TBS-1, 4.5% B.I.D

EXPERIMENTAL

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)

Drug: 13.5 mg of Testosterone, 4.5% B.I.D

11.25 mg of TBS-1, 4.5% T.I.D

EXPERIMENTAL

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)

Drug: 11.25 mg of Testosterone, 4.5% T.I.D

Interventions

10.0 mg of Testosterone, 4.0% TID DRUG

Also known as: 10.0 mg of TBS-1, 4.0% TID

10.0 mg of TBS-1, 4.0% T.I.D.

13.5 mg of Testosterone, 4.5% B.I.D DRUG

Also known as: 13.5 mg of TBS-1, 4.5% B.I.D

13.5 mg of TBS-1, 4.5% B.I.D

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

Also known as: 11.25 mg of TBS-1, 4.5% T.I.D

11.25 mg of TBS-1, 4.5% T.I.D

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acerus Pharmaceuticals Corporation: lead

Study Sites (3)

Quality of Life Medical and Research Center

Tucson, Arizona, United States

Location

Pharmax Research Clinic Inc.

Miami, Florida, United States

Location

Regional Urology LLC

Shreveport, Louisiana, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Vice President
• Organization: Acerus Pharmaceuticals Corporation

nbryson@aceruspharma.com

(416) 679-0776

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 23, 2018
• Results First Posted: April 26, 2018

Record last verified: 2018-04

Locations

US (3)