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

25 september 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

180

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Testosterongel (FE 999303)

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

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Sponsor

Ferring Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2012

Primärt slutförande (Faktisk)

1 april 2013

Avslutad studie (Faktisk)

1 maj 2013

Studieregistreringsdatum

Först inskickad

1 augusti 2012

Först inskickad som uppfyllde QC-kriterierna

10 augusti 2012

Första postat (Uppskatta)

15 augusti 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 oktober 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2017

Senast verifierad

1 september 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 000023

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