- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01665599
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Ontario
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London, Ontario, Canada
- St. Joseph's Healthcare
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North Bay, Ontario, Canada
- Private Practice and Clinical Research
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Alabama
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Huntsville, Alabama, États-Unis
- Medical Affiliated Research Cente
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California
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Newport Beach, California, États-Unis
- California Professional Research
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San Diego, California, États-Unis
- San Diego Sexual Medicine
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Connecticut
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Middlebury, Connecticut, États-Unis
- Connecticut Clinical Research
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Florida
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Aventura, Florida, États-Unis
- South Florida Medical Research
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Michigan
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Saint Clair Shores, Michigan, États-Unis
- Michigan Institute of Urology
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Nebraska
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Omaha, Nebraska, États-Unis
- Quality Clinical Research
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New Jersey
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Lawrenceville, New Jersey, États-Unis
- Premier Urology Associates
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New York
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New York, New York, États-Unis
- University Urology
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Poughkeepsie, New York, États-Unis
- Premier Medical Group of the Hudson Valley
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North Carolina
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Winston-Salem, North Carolina, États-Unis
- PMG Research of Wilmington
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Ohio
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Cincinnati, Ohio, États-Unis
- Tristate Urologic Services
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Rhode Island
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Warwick, Rhode Island, États-Unis
- Omega Medical Research
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South Carolina
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Mount Pleasant, South Carolina, États-Unis
- Coastal Carolina Research Center
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Myrtle Beach, South Carolina, États-Unis
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, États-Unis
- Clinical Research Associates
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Texas
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Dallas, Texas, États-Unis
- Urology Clinics of North Texas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Males between 18-75 years of age
- Two screening serum testosterone values less than 300 ng/dL
- One or more symptoms of testosterone deficiency
Exclusion Criteria:
- Previous use of the investigational product
- Use of any investigational product within 30 days prior to screening and during the study
- BMI less than 18 kg/m^2 or more than 35 kg/m^2
- Prostatic mass(es)
- Generalized skin irritation or skin disease
- Lower urinary tract obstruction
- Myocardial infarction or cerebrovascular accident in the last 6 months
- Unstable angina or congestive heart failure
- Thromboembolic disorders
- Sleep apnea
- Hyperparathyroidism or uncontrolled diabetes
- Untreated moderate to severe depression
- History of testicular, prostate, or breast cancer
- HIV, Hepatitis B, or Hepatitis C positive
- PSA more or equal to 3 ng/mL
- Use of any medications that could be considered anabolic
- Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
- Chronic use of any drug of abuse
- Involvement in a sport in which there is a screening for anabolic steroids
- Not willing to use adequate contraception during the study
- Partner is pregnant and/or breast feeding
- Partner has a history of breast, uterine or ovarian cancer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Testosterone gel (FE 999303)
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Délai: Day 90
|
The data were presented using descriptive statistics.
No statistical analysis was performed.
|
Day 90
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Délai: Day 1
|
The data were presented using descriptive statistics.
No statistical analysis was performed.
|
Day 1
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Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Délai: Day 1; Day 90
|
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.
|
Day 1; Day 90
|
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of total testosterone.
|
Day 1; Day 90
|
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of total testosterone.
|
Day 1; Day 90
|
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of total testosterone.
|
Day 1; Day 90
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Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of total testosterone.
|
Day 1; Day 90
|
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of total testosterone.
|
Day 1; Day 90
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Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
|
Day 1; Day 90
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Pharmacokinetics of DHT Measuring Tmax
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
|
Day 1; Day 90
|
Pharmacokinetics of DHT Measuring Cmax
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
|
Day 1; Day 90
|
Pharmacokinetics of DHT Measuring Cave
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
|
Day 1; Day 90
|
Pharmacokinetics of DHT Measuring Cmin
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
|
Day 1; Day 90
|
Pharmacokinetics of DHT Measuring Tmin
Délai: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
|
Day 1; Day 90
|
Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
Délai: Day 91
|
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 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. |
Day 91
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Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Délai: Day 91
|
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 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. |
Day 91
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Change From Baseline in the SF-12 Health Questionnaire
Délai: Day 91
|
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 standard deviation 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. |
Day 91
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 000023
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