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Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days. In addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. Related Outcome Measures will be reported for Parts 1, 2, and 4.
A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported for Part 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: 120 mg BID | Experimental | Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days |
|
| Part 1: 240 mg BID | Experimental | Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days |
|
| Part 2: 120 mg BID | Experimental | Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days |
|
| Part 3: A-B-C 120 mg QD | Experimental | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
|
|
| Part 3: B-C-A 120 mg QD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSX-002 | Drug | TSX-002 are capsules with testosterone as the active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002 | Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment | Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Cavg 0-24 Hrs (ng/dL) After 120 mg Dose | PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects. | 24 hrs |
| AUC 0-24 Hrs After 120 mg Dose of TSX-002 |
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| John Kowalczyk, DO, FACOS | Urology Group of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Group of Southern California | Los Angeles | California | 90048 | United States |
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130 subjects were recruited at 1 center in the US from October 2012 to May 2014. The study was designed with 4 parts, including 9 different dosages of the investigational drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: 120 mg BID | Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG001 | Part 1: 240 mg BID | Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG002 | Part 2: 120 mg BID | Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG003 | Part 3: A-B-C 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG004 | Part 3: B-C-A 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
|
| FG005 | Part 3: C-A-B 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
|
| FG006 | Part 4 Cohort 1: 60 mg BID | Oral TSX-002 60 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG007 | Part 4 Cohort 1: 60 mg TID | Oral TSX-002 60 mg TID for 15 days TSX-002 are capsules with testosterone as the active ingredient. |
| FG008 | Part 4 Cohort 2: 90 mg BID | Oral TSX-002 90 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG009 | Part 4 Cohort 2: 90 mg TID | Oral TSX-002 90 mg TID for 15 days |
| FG010 | Part 4 Cohort 3: 180 mg QD | Oral TSX-002 180 mg once daily (QD) for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| FG011 | Part 4 Cohort 4: 120 mg BID | Oral TSX-002 120 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Duration of 15 Days) |
|
| ||||||||||||||||||
| Part 2 (Duration of 15 Days) |
| |||||||||||||||||||
| Part 3 - Treatment 1 (Duration of 1 Day) |
| |||||||||||||||||||
| Part 3 - Treatment 2 (Duration of 1 Day) |
| |||||||||||||||||||
| Part 3 - Treatment 3 (Duration of 1 Day) |
| |||||||||||||||||||
| Part 4-Treatment 1 (Duration of 15 Days) |
| |||||||||||||||||||
| Part 4-Treatment 2 (Duration of 15 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: 120 mg BID | Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG001 | Part 1: 240 mg BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002 | Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4. | All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone. | Posted | Number | percentage of participants | 15 days |
|
The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
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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 | Part 1: 120 mg BID | Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Oefelein, MD, Chief Medical Officer | TesoRx Pharma LLC | 909-595-0500 | 104 | karl@tesorx.com |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| 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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| Experimental |
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
|
|
| Part 3: C-A-B 120 mg QD | Experimental | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
|
|
| Part 4 Cohort 1: 60 mg BID/ 60 mg TID | Experimental | Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days |
|
| Part 4 Cohort 2: 90 mg BID/ 90 mg TID | Experimental | Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days |
|
| Part 4 Cohort 3: 180 mg QD | Experimental | Oral TSX-002 180 mg once daily (QD) for 15 days |
|
| Part 4 Cohort 4: 120 mg BID | Experimental | Oral TSX-002 120 mg BID for 15 days |
|
|
| 15 days |
AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. |
| 24 hrs |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
| BG002 | Part 2: 120 mg BID | Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG003 | Part 3: A-B-C 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG004 | Part 3: B-C-A 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG005 | Part 3: C-A-B 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG006 | Part 4 Cohort 1: 60 mg BID/ 60 mg TID | Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG007 | Part 4 Cohort 2: 90 mg BID/ 90 mg TID | Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG008 | Part 4 Cohort 3: 180 mg QD | Oral TSX-002 180 mg once daily (QD) for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG009 | Part 4 Cohort 4: 120 mg BID | Oral TSX-002 120 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| BG010 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Part 1: 120 mg BID |
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG001 | Part 1: 240 mg BID | Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG002 | Part 2: 120 mg BID | Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG003 | Part 4 Cohort 1: 60 mg BID | Oral TSX-002 60 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG004 | Part 4 Cohort 1: 60 mg TID | Oral TSX-002 60 mg three times daily (TID) for 15 days |
| OG005 | Part 4 Cohort 2: 90 mg BID | Oral TSX-002 90 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG006 | Part 4 Cohort 2: 90 mg TID | Oral TSX-002 90 mg TID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG007 | Part 4 Cohort 3: 180 mg QD | Oral TSX-002 180 mg once daily (QD) for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
| OG008 | Part 4 Cohort 4: 120 mg BID | Oral TSX-002 120 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. |
|
|
| Secondary | Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment | Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4. | All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone. | Posted | Number | percentage of subjects | 15 days |
|
|
|
| Other Pre-specified | Cavg 0-24 Hrs (ng/dL) After 120 mg Dose | PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects. | All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal). | Posted | Least Squares Mean | Standard Deviation | ng/dL | 24 hrs |
|
|
|
| Other Pre-specified | AUC 0-24 Hrs After 120 mg Dose of TSX-002 | AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. | All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal). | Posted | Median | Standard Deviation | hr×ng/dL | 24 hrs |
|
|
|
| 0 |
| 17 |
| 6 |
| 17 |
| EG001 | Part 1: 240 mg BID | Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 17 | 8 | 17 |
| EG002 | Part 2: 120 mg BID | Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 17 | 6 | 17 |
| EG003 | Part 3: A-B-C 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 4 | 0 | 4 |
| EG004 | Part 3: B-C-A 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 5 | 2 | 5 |
| EG005 | Part 3: C-A-B 120 mg QD | Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 5 | 2 | 5 |
| EG006 | Part 4 Cohort 1: 60 mg BID | Oral TSX-002 60 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 17 | 3 | 17 |
| EG007 | Part 4 Cohort 1: 60 mg TID | Oral TSX-002 60 mg TID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 17 | 3 | 17 |
| EG008 | Part 4 Cohort 2: 90 mg BID | Oral TSX-002 90 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 16 | 0 | 16 |
| EG009 | Part 4 Cohort 2: 90 mg TID | Oral TSX-002 90 mg TID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 16 | 2 | 16 |
| EG010 | Part 4 Cohort 3: 180 mg QD | Oral TSX-002 180 mg once daily (QD) for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 16 | 6 | 16 |
| EG011 | Part 4 Cohort 4: 120 mg BID | Oral TSX-002 120 mg BID for 15 days TSX-002: TSX-002 are capsules with testosterone as the active ingredient. | 0 | 16 | 3 | 16 |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Catheter site phlebitis | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sluggishness | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
Restriction Description: At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.
| 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 |
| Percentage of subjects with Cmax ≥ 1800 and ≤ 2500 |
|
| Percentage of subjects with Cmax > 2500 ng/dL afte |
|