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This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone gel (FE 999093) | Experimental | Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Gel (FE 999093) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. | Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center | Huntsville | Alabama | United States | |||
| California Professional Research |
Of the 172 subjects who completed study 000023 (NCT01665599), 145 subjects were enrolled into this extension study and continued to receive treatment (23 mg, 46 mg or 69 mg).
Subjects were recruited from 16 study centers in United States and 2 study centers in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Gel (FE 999303) | Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain. | At Month 6 |
| Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire | In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions. The data were presented using descriptive statistics. | At Month 6 |
| Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire | The MAF contains four sub-domains:
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue. To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue). The data were presented using descriptive statistics. | At Month 6 |
| Domain Scores for the Short Form-12 (SF-12) Questionnaire | Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains: PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item) MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item) The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The data were presented using descriptive statistics. | At Month 6 |
| Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | The data were presented using descriptive statistics. | At Month 3 |
| Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | The data were presented using descriptive statistics. | At Month 6 |
| Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
| Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
| Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
| Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
| Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
| Newport Beach |
| California |
| United States |
| San Diego Sexual Medicine | San Diego | California | United States |
| Connecticut Clinical Research | Middlebury | Connecticut | United States |
| South Florida Medical Research | Aventura | Florida | United States |
| Michigan Institute of Urology | Saint Clair Shores | Michigan | United States |
| Premier Urology Associates | Lawrenceville | New Jersey | United States |
| University Urology | New York | New York | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | United States |
| PMG Research of Wilmington | Winston-Salem | North Carolina | United States |
| Tristate Urologic Services | Cincinnati | Ohio | United States |
| Omega Medical Research | Warwick | Rhode Island | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States |
| Clinical Research Associates | Nashville | Tennessee | United States |
| Urology Clinics of North Texas | Dallas | Texas | United States |
| St. Joseph's Healthcare | London | Ontario | Canada |
| Private Practice and Clinical Research | North Bay | Ontario | Canada |
| Per Protocol (PP) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) Population consists of all subjects who received at least one dose of Investigational Medicinal Product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Gel (FE 999303) | Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Number | percentage of subjects | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. | Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Number | percentage of subjects | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:
A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain. | ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results. | Posted | Mean | Standard Deviation | units on a scale | At Month 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire | In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions. The data were presented using descriptive statistics. | ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results. | Posted | Number | percentage of subjects | At Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire | The MAF contains four sub-domains:
A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue. To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue). The data were presented using descriptive statistics. | ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results. | Posted | Mean | Standard Deviation | units on a scale | At Month 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Domain Scores for the Short Form-12 (SF-12) Questionnaire | Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains: PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item) MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item) The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The data were presented using descriptive statistics. | ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results. | Posted | Mean | Standard Deviation | units on a scale | At Month 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Number | percentage of subjects | At Month 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Number | percentage of subjects | At Month 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Mean | Standard Deviation | ng*hr/dL | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Median | Full Range | hour | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) |
|
|
Overall study period (From Day 1 to Month 6)
The treatment-emergent adverse event (TEAE), defined as any adverse event (AE) occurring after start of IMP administration and within the time of residual drug effect (5 days of the last dosing), or a pretreatment AE or pre-existing medical condition that worsens in intensity after treatment with the IMP and within the time of residual drug effect, were presented.
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 | Testosterone Gel (FE 999303) | Subjects received testosterone gel with initial dose as fixed on Day 56 during the 000023 study. The dose was further down titrated based on serum testosterone levels. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion. | 1 | 145 | 28 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haematocrit abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Red blood cell count abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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