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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01665599
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : September 20, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adult Male Hypogonadism Drug: Testosterone gel (FE 999303) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: Testosterone gel (FE 999303)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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:

    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.


  15. Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire [ Time Frame: 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.


  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665599


Locations
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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01665599    
Other Study ID Numbers: 000023
First Posted: August 15, 2012    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: October 26, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs