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Efficacy of an Intranasal Testosterone Product

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
Acerus Pharmaceuticals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Quality of Life Medical and Research Center
  • Pharmax Research Clinic Inc.
  • Regional Urology LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

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

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

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Cmax of Serum Testosterone
Cavg of Serum Testosterone
AUC0-t of Serum Testosterone

Secondary Outcome Measures

Full Information

First Posted
December 1, 2010
Last Updated
April 25, 2018
Sponsor
Acerus Pharmaceuticals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01252745
Brief Title
Efficacy of an Intranasal Testosterone Product
Official Title
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerus Pharmaceuticals Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10.0 mg of TBS-1, 4.0% T.I.D.
Arm Type
Experimental
Arm Description
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)
Arm Title
13.5 mg of TBS-1, 4.5% B.I.D
Arm Type
Experimental
Arm Description
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)
Arm Title
11.25 mg of TBS-1, 4.5% T.I.D
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
10.0 mg of Testosterone, 4.0% TID
Other Intervention Name(s)
10.0 mg of TBS-1, 4.0% TID
Intervention Type
Drug
Intervention Name(s)
13.5 mg of Testosterone, 4.5% B.I.D
Other Intervention Name(s)
13.5 mg of TBS-1, 4.5% B.I.D
Intervention Type
Drug
Intervention Name(s)
11.25 mg of Testosterone, 4.5% T.I.D
Other Intervention Name(s)
11.25 mg of TBS-1, 4.5% T.I.D
Primary Outcome Measure Information:
Title
Cmax of Serum Testosterone
Time Frame
24 hours
Title
Cavg of Serum Testosterone
Time Frame
24 hours
Title
AUC0-t of Serum Testosterone
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Quality of Life Medical and Research Center
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Pharmax Research Clinic Inc.
City
Miami
State/Province
Florida
Country
United States
Facility Name
Regional Urology LLC
City
Shreveport
State/Province
Louisiana
Country
United States

12. IPD Sharing Statement

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Efficacy of an Intranasal Testosterone Product

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