NCT00975650

Brief Summary

This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

August 13, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

September 10, 2009

Results QC Date

March 9, 2018

Last Update Submit

August 9, 2018

Conditions

Hypogonadism

Keywords

Primary HypogonadismSecondary Hypogonadism

Outcome Measures

Primary Outcomes (7)

  • Serum Testosterone Ln-Cmax

    The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.

    0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

  • Serum Testosterone Ln-AUCt

    0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

  • Serum Testosterone Cavg

    0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

  • Serum Dihydrotestosterone Ln-Cmax

    0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

  • Serum Dihydrotestosterone Ln-AUCt

    0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

  • Serum Dihydrotestosterone Cavg

    0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.

  • Percentage of Subjects With Cavg Within the Reference Range

    The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.

    Each period is 7 days

Study Arms (4)

Test 8.0, Ref 5.0, Test 14.0, Test 11.0

EXPERIMENTAL

Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;

Drug: Nasobol®Drug: Androderm® (Positive Control)

Test 11.0, Test 8.0, Ref 5.0, Test 14.0

EXPERIMENTAL

Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days

Drug: Nasobol®Drug: Androderm® (Positive Control)

Test 14.0, Test 11.0, Test 8.0, Ref 5.0

EXPERIMENTAL

Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days;

Drug: Nasobol®Drug: Androderm® (Positive Control)

Ref 5.0, Test 14.0, Test 11.0, Test 8.0

EXPERIMENTAL

Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days

Drug: Nasobol®Drug: Androderm® (Positive Control)

Interventions

Nasobol®DRUG

Intra-nasal Testosterone (2 syringes), b.i.d.

Ref 5.0, Test 14.0, Test 11.0, Test 8.0Test 11.0, Test 8.0, Ref 5.0, Test 14.0Test 14.0, Test 11.0, Test 8.0, Ref 5.0Test 8.0, Ref 5.0, Test 14.0, Test 11.0
Androderm® (Positive Control)DRUG

QD administration

Ref 5.0, Test 14.0, Test 11.0, Test 8.0Test 11.0, Test 8.0, Ref 5.0, Test 14.0Test 14.0, Test 11.0, Test 8.0, Ref 5.0Test 8.0, Ref 5.0, Test 14.0, Test 11.0

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Quality of Life Medical & Research centre

Tucson, Arizona, 85712, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Cetero Research

Miami Gardens, Florida, 33169, United States

Location

Clinical Research Institute

Wichita, Kansas, 67221, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

dgd Research Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Nathan Bryson, Vice President, Scientific Affairs
Organization
Acerus Pharmaceuticals Corporation
nbryson@aceruspharma.com
1-416-679-0776

Study Officials

  • Paul Desjardins, Ph.D

    Trimel Biopharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 13, 2018

Results First Posted

August 13, 2018

Record last verified: 2018-08

Locations

US(6)