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

25. september 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

180

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Testosteron gel (FE 999303)

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ferring Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

1. august 2012

Først indsendt, der opfyldte QC-kriterier

10. august 2012

Først opslået (Skøn)

15. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 000023

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hypogonadisme hos voksne mænd

Kliniske forsøg med Testosteron gel (FE 999303)

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner