Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TBS1-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Primary Objective:
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, and comparing it to that of the active control, Androderm®.
Secondary Objective:
To establish a safety profile for Nasobol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| 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 |
|
| 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; |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasobol® | Drug | Intra-nasal Testosterone (2 syringes), b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Desjardins, Ph.D | Trimel Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quality of Life Medical & Research centre | Tucson | Arizona | 85712 | United States | ||
| Providence Clinical Research |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | 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; |
| FG001 | Sequence 2 | 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 |
| FG002 | Sequence 3 | 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 |
| FG003 | Sequence 4 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
| |||||||||||||
| Period 4 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All Subjects who were dosed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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®. | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Mean | Standard Deviation | ng/dL | 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. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathan Bryson, Vice President, Scientific Affairs | Acerus Pharmaceuticals Corporation | 1-416-679-0776 | nbryson@aceruspharma.com |
Not provided
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Androderm® (Positive Control) | Drug | QD administration |
|
| Each period is 7 days |
| Burbank |
| California |
| 91505 |
| United States |
| Cetero Research | Miami Gardens | Florida | 33169 | United States |
| Clinical Research Institute | Wichita | Kansas | 67221 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| dgd Research Inc. | San Antonio | Texas | 78229 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Treatment B |
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days |
| OG002 | Treatment C | Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days |
| OG003 | Treatment D | Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days |
|
|
| Primary | Serum Testosterone Ln-AUCt | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Mean | Standard Deviation | ng.h/dL | 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. |
|
|
|
| Primary | Serum Testosterone Cavg | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Mean | Standard Deviation | ng/dL | 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. |
|
|
|
| Primary | Serum Dihydrotestosterone Ln-Cmax | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Mean | Standard Deviation | ng/dL | 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. |
|
|
|
| Primary | Serum Dihydrotestosterone Ln-AUCt | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Mean | Standard Deviation | ng.h/dL | 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. |
|
|
|
| Primary | Serum Dihydrotestosterone Cavg | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Mean | Standard Deviation | ng/dL | 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. |
|
|
|
| Primary | 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. | Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter. | Posted | Count of Participants | Participants | Each period is 7 days |
|
|
|
| 57 |
| 0 |
| 57 |
| 5 |
| 57 |
| EG001 | Treatment B | Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days | 0 | 56 | 0 | 56 | 6 | 56 |
| EG002 | Treatment C | Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days | 0 | 54 | 0 | 54 | 0 | 54 |
| EG003 | Treatment D | Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days | 0 | 55 | 0 | 55 | 6 | 55 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Application Site Rash | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Dihydrotestosterone |
|