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Completed

NCT Number: NCT01665599

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

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.

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Key information

Conditions

Adult Male Hypogonadism Endocrine System Diseases Eunuchism Gonadal Disorders Hypogonadism

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

St. Joseph's Healthcare, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone gel (FE 999303)

Drug

Primary outcomes

  1. The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL

    Time frame: Day 90

    The data were presented using descriptive statistics. No statistical analysis was performed.

Secondary outcomes

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

    Time frame: Day 1

    The data were presented using descriptive statistics. No statistical analysis was performed.

  2. Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)

    Time frame: 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.

  3. Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of total testosterone.

  4. Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of total testosterone.

  5. Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of total testosterone.

  6. Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of total testosterone.

  7. Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of total testosterone.

  8. Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of DHT.

  9. Pharmacokinetics of DHT Measuring Tmax

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of DHT.

  10. Pharmacokinetics of DHT Measuring Cmax

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of DHT.

  11. Pharmacokinetics of DHT Measuring Cave

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of DHT.

  12. Pharmacokinetics of DHT Measuring Cmin

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of DHT.

  13. Pharmacokinetics of DHT Measuring Tmin

    Time frame: Day 1; Day 90

    A validated LC/MS/MS method was used to determine the levels of DHT.

  14. Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire

    Time frame: Day 91

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

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

  15. Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire

    Time frame: Day 91

    The MAF contains four sub-domains:

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

  16. Change From Baseline in the SF-12 Health Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 15, 2012
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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