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This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10.0 mg of Testosterone, 4.0% TID | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Serum Testosterone | 24 hours | |
| Cavg of Serum Testosterone | 24 hours | |
| AUC0-t of Serum Testosterone | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quality of Life Medical and Research Center | Tucson | Arizona | United States | |||
| Pharmax Research Clinic Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10.0 mg Testosterone t.i.d. | 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) |
| FG001 | 13.5 mg Testosterone 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) |
| FG002 | 11.25 mg Testosterone 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10.0 mg Testosterone t.i.d. | 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) |
| BG001 | 13.5 mg Testosterone b.i.d. |
| 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 | Cmax of Serum Testosterone | Posted | Mean | Standard Deviation | ng/dL | 24 hours |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10.0 mg Testosterone t.i.d. | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President | Acerus Pharmaceuticals Corporation | (416) 679-0776 | nbryson@aceruspharma.com |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| 13.5 mg of Testosterone, 4.5% B.I.D |
| Drug |
|
|
| 11.25 mg of Testosterone, 4.5% T.I.D | Drug |
|
|
| Miami |
| Florida |
| United States |
| Regional Urology LLC | Shreveport | Louisiana | United States |
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) |
| BG002 | 11.25 mg Testosterone 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) |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
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 | Cavg of Serum Testosterone | Posted | Mean | Standard Deviation | ng/dL | 24 hours |
|
|
|
| Primary | AUC0-t of Serum Testosterone | Posted | Mean | Standard Deviation | ng.h/dL | 24 hours |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | 13.5 mg Testosterone 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) | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | 11.25 mg Testosterone 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) | 0 | 7 | 0 | 7 | 0 | 7 |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Excoriation | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment | Unrelated to Study Treatment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment | Unrelated to Study Treatment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment | Unrelated to the Study Treatment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment | Unrelated to the Study Treatment |
|
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| 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 |