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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Ontario
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London, Ontario, Canadá
- St. Joseph's Healthcare
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North Bay, Ontario, Canadá
- Private Practice and Clinical Research
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Alabama
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Huntsville, Alabama, Estados Unidos
- Medical Affiliated Research Cente
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California
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Newport Beach, California, Estados Unidos
- California Professional Research
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San Diego, California, Estados Unidos
- San Diego Sexual Medicine
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Connecticut
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Middlebury, Connecticut, Estados Unidos
- Connecticut Clinical Research
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Florida
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Aventura, Florida, Estados Unidos
- South Florida Medical Research
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Michigan
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Saint Clair Shores, Michigan, Estados Unidos
- Michigan Institute of Urology
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Nebraska
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Omaha, Nebraska, Estados Unidos
- Quality Clinical Research
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New Jersey
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Lawrenceville, New Jersey, Estados Unidos
- Premier Urology Associates
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New York
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New York, New York, Estados Unidos
- University Urology
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Poughkeepsie, New York, Estados Unidos
- Premier Medical Group of the Hudson Valley
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos
- PMG Research of Wilmington
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Ohio
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Cincinnati, Ohio, Estados Unidos
- Tristate Urologic Services
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Rhode Island
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Warwick, Rhode Island, Estados Unidos
- Omega Medical Research
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South Carolina
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Mount Pleasant, South Carolina, Estados Unidos
- Coastal Carolina Research Center
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Myrtle Beach, South Carolina, Estados Unidos
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, Estados Unidos
- Clinical Research Associates
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Texas
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Dallas, Texas, Estados Unidos
- Urology Clinics of North Texas
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Prazo: Day 90
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The data were presented using descriptive statistics.
No statistical analysis was performed.
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Day 90
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Prazo: Day 1
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The data were presented using descriptive statistics.
No statistical analysis was performed.
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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)
Prazo: Day 1; Day 90
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A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.
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Day 1; Day 90
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Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Prazo: Day 1; Day 90
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A validated LC/MS/MS method was used to determine the levels of total testosterone.
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Day 1; Day 90
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Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Prazo: Day 1; Day 90
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A validated LC/MS/MS method was used to determine the levels of total testosterone.
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Day 1; Day 90
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Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Prazo: Day 1; Day 90
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A validated LC/MS/MS method was used to determine the levels of total testosterone.
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Day 1; Day 90
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Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Prazo: Day 1; Day 90
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A validated LC/MS/MS method was used to determine the levels of total testosterone.
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Day 1; Day 90
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Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Prazo: Day 1; Day 90
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A validated LC/MS/MS method was used to determine the levels of total testosterone.
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Day 1; Day 90
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Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Prazo: Day 1; Day 90
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A validated LC/MS/MS method was used to determine the levels of DHT.
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Day 1; Day 90
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Pharmacokinetics of DHT Measuring Tmax
Prazo: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
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Day 1; Day 90
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Pharmacokinetics of DHT Measuring Cmax
Prazo: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
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Day 1; Day 90
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Pharmacokinetics of DHT Measuring Cave
Prazo: 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 Cmin
Prazo: 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 Tmin
Prazo: Day 1; Day 90
|
A validated LC/MS/MS method was used to determine the levels of DHT.
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Day 1; Day 90
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Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
Prazo: Day 91
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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
Prazo: Day 91
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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
Prazo: Day 91
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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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Última Atualização Postada (Real)
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Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 000023
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