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

25 september 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

180

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Testosterongel (FE 999303)

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ferring Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2012

Primaire voltooiing (Werkelijk)

1 april 2013

Studie voltooiing (Werkelijk)

1 mei 2013

Studieregistratiedata

Eerst ingediend

1 augustus 2012

Eerst ingediend dat voldeed aan de QC-criteria

10 augustus 2012

Eerst geplaatst (Schatting)

15 augustus 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

25 september 2017

Laatst geverifieerd

1 september 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 000023

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