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This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone gel (FE 999303) | Experimental | Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone gel (FE 999303) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%. | At Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | The data were presented using descriptive statistics. No statistical analysis was performed. | At 14, 35 and 56 |
| Change From Baseline in International Index of Erectile Function (IIEF) Score |
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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 |
|---|---|---|---|---|---|---|
| Investigational site | Anniston | Alabama | United States | |||
| Investigational site |
Of the 940 screened subjects, 160 subjects were eligible to be enrolled into the study.
Subjects were recruited from 23 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Gel (FE 999303) | Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:
A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function. |
| At Days 35 and 90 |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | 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 (categorical in nature) are scored from 1-4. The scores are 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 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. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue). | At Days 35 and 90 |
| Change From Baseline in Short Form-12 Health Survey (SF-12) Score | Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains: PCS:
MCS:
PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health. | At Days 35 and 90 |
| Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone | A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone. | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
| Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
| Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
| Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
| Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
| Huntsville |
| Alabama |
| United States |
| Investigational site | Newport Beach | California | United States |
| Investigational site | Denver | Colorado | United States |
| Investigational site | New Haven | Connecticut | United States |
| Investigational site | Aventura | Florida | United States |
| Investigational site | Clearwater | Florida | United States |
| Investigational site | Mishawaka | Indiana | United States |
| Investigational site | Watertown | Massachusetts | United States |
| Investigational site | Troy | Michigan | United States |
| Investigational site | Edison | New Jersey | United States |
| Investigational site | Lawrence | New Jersey | United States |
| Investigational site | Garden City | New York | United States |
| Investigational site | New York | New York | United States |
| Investigational site | Poughkeepsie | New York | United States |
| Investigational site | Purchase | New York | United States |
| Investigational site | Bala-Cynwyd | Pennsylvania | United States |
| Investigational site | Warwick | Rhode Island | United States |
| Investigational site | Mt. Pleasant | South Carolina | United States |
| Investigational site | Nashville | Tennessee | United States |
| Investigational site | Webster | Texas | United States |
| Investigational site | Norfolk | Virginia | United States |
| 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 at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm. |
| 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 |
| ||||||||||||||||||||
| Height | Mean | Standard Deviation | inches |
| |||||||||||||||||||
| Weight | Mean | Standard Deviation | lbs |
| |||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||
| Total International Index of Erectile Function Score - All Domains | IIEF questionnaire have 15 questions (Q) divided into 5 domains-
Total score was calculated by summing up scores of each domain and ranged from 5-75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||
| Multidimensional Assessment of Fatigue | The MAF have 16 questions (Q) divided into 4 domains:
First 14 Q are scored from 1-10. Questions 15-16 are scored from 1-4 and converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue. GFI was calculated by summing up scores of Q 1, 2, 3, average of 4-14, and revised score of 15. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||||
| Short Form -12 (SF-12) Health survey | Data collected from the SF-12 questionnaire, based on the norm-based scores is 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 (A total of 12 questions). PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicates improvement in physical and mental health. | Mean | Standard Deviation | units on a scale |
|
| 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 | The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%. | Full Analysis Set (FAS) population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | Posted | Number | 95% Confidence Interval | percentage of subjects | At Day 90 |
|
|
| |||||||||||||||||||||||||
| Secondary | The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | The data were presented using descriptive statistics. No statistical analysis was performed. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | Posted | Number | percentage of subjects | At 14, 35 and 56 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in International Index of Erectile Function (IIEF) Score | Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:
A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | Posted | Mean | Standard Deviation | units on a scale | At Days 35 and 90 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | 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 (categorical in nature) are scored from 1-4. The scores are 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 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. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue). | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | Posted | Mean | Standard Deviation | units on a scale | At Days 35 and 90 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form-12 Health Survey (SF-12) Score | Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains: PCS:
MCS:
PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | Posted | Mean | Standard Deviation | units on a scale | At Days 35 and 90 |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone | A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point. | Posted | Mean | Standard Deviation | ng/dL | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point. | Posted | Mean | Standard Deviation | ng*hr/dL | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to adverse event after Day 14 visit and not included in the analysis. | Posted | Median | Full Range | hr | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis. | Posted | Mean | Standard Deviation | ng/dL | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone | A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone. | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis. | Posted | Mean | Standard Deviation | ng/dL | Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 |
|
|
Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
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 at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm. | 5 | 159 | 54 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sluggishness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-glutamyl transferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyposmia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Prostatic pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Testicular atrophy | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hot flush | 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 |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Degree of interference domain |
|
| Timing domain |
|
| Global Fatigue Index (GFI) |
|
| Title | Measurements |
|---|---|
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| Participants |
|
|
| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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