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A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

25 de septiembre de 2017 actualizado por: Ferring Pharmaceuticals

A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

180

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Ontario
      • London, Ontario, Canadá
        • St. Joseph's Healthcare
      • North Bay, Ontario, Canadá
        • Private Practice and Clinical Research
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos
        • Medical Affiliated Research Cente
    • California
      • Newport Beach, California, Estados Unidos
        • California Professional Research
      • San Diego, California, Estados Unidos
        • San Diego Sexual Medicine
    • Connecticut
      • Middlebury, Connecticut, Estados Unidos
        • Connecticut Clinical Research
    • Florida
      • Aventura, Florida, Estados Unidos
        • South Florida Medical Research
    • Michigan
      • Saint Clair Shores, Michigan, Estados Unidos
        • Michigan Institute of Urology
    • Nebraska
      • Omaha, Nebraska, Estados Unidos
        • Quality Clinical Research
    • New Jersey
      • Lawrenceville, New Jersey, Estados Unidos
        • Premier Urology Associates
    • New York
      • New York, New York, Estados Unidos
        • University Urology
      • Poughkeepsie, New York, Estados Unidos
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos
        • PMG Research of Wilmington
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
        • Tristate Urologic Services
    • Rhode Island
      • Warwick, Rhode Island, Estados Unidos
        • Omega Medical Research
    • South Carolina
      • Mount Pleasant, South Carolina, Estados Unidos
        • Coastal Carolina Research Center
      • Myrtle Beach, South Carolina, Estados Unidos
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, Estados Unidos
        • Clinical Research Associates
    • Texas
      • Dallas, Texas, Estados Unidos
        • Urology Clinics of North Texas

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  1. Males between 18-75 years of age
  2. Two screening serum testosterone values less than 300 ng/dL
  3. One or more symptoms of testosterone deficiency

Exclusion Criteria:

  1. Previous use of the investigational product
  2. Use of any investigational product within 30 days prior to screening and during the study
  3. BMI less than 18 kg/m^2 or more than 35 kg/m^2
  4. Prostatic mass(es)
  5. Generalized skin irritation or skin disease
  6. Lower urinary tract obstruction
  7. Myocardial infarction or cerebrovascular accident in the last 6 months
  8. Unstable angina or congestive heart failure
  9. Thromboembolic disorders
  10. Sleep apnea
  11. Hyperparathyroidism or uncontrolled diabetes
  12. Untreated moderate to severe depression
  13. History of testicular, prostate, or breast cancer
  14. HIV, Hepatitis B, or Hepatitis C positive
  15. PSA more or equal to 3 ng/mL
  16. Use of any medications that could be considered anabolic
  17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
  18. Chronic use of any drug of abuse
  19. Involvement in a sport in which there is a screening for anabolic steroids
  20. Not willing to use adequate contraception during the study
  21. Partner is pregnant and/or breast feeding
  22. Partner has a history of breast, uterine or ovarian cancer

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: Gel de testosterona (FE 999303)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Periodo de tiempo: Day 90
The data were presented using descriptive statistics. No statistical analysis was performed.
Day 90

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Periodo de tiempo: Day 1
The data were presented using descriptive statistics. No statistical analysis was performed.
Day 1
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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 Minimum Concentration Observed (Cmin)
Periodo de tiempo: 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)
Periodo de tiempo: 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 DHT (Dihydrotestosterone) Measuring AUCτ
Periodo de tiempo: 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 Tmax
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 91

Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:

  1. Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)
  2. Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
  3. Sexual desire (2 items, questions 11-12) (Score range: 2-10)
  4. Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
  5. Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)

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
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Periodo de tiempo: Day 91

The MAF contains four sub-domains:

  1. Severity (2 items, questions 1-2) (Score range: 2-20)
  2. Distress (1 item, question 3) (Score range: 1-10)
  3. Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
  4. Timing (2 items, questions 15-16) (Score range: 5-20)

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
Change From Baseline in the SF-12 Health Questionnaire
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ferring Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2012

Finalización primaria (Actual)

1 de abril de 2013

Finalización del estudio (Actual)

1 de mayo de 2013

Fechas de registro del estudio

Enviado por primera vez

1 de agosto de 2012

Primero enviado que cumplió con los criterios de control de calidad

10 de agosto de 2012

Publicado por primera vez (Estimar)

15 de agosto de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de octubre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

25 de septiembre de 2017

Última verificación

1 de septiembre de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 000023

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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