We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665599
First Posted: August 15, 2012
Last Update Posted: September 20, 2017
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.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose
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 Intervention Phase
Adult Male Hypogonadism Drug: Testosterone gel (FE 999303) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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: 0-30)
    2. Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
    3. Sexual desire (2 items, questions 11-12) (Score range: 0-10)
    4. Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
    5. Overall satisfaction (2 items, questions 13-14) (Score range: 0-10)

    A score of 0-5 is awarded to each of 15 questions. Total score was calculated by summing up scores of each domain. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.


  • 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.


  • 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.



Enrollment: 180
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
United States, Alabama
Medical Affiliated Research Cente
Huntsville, Alabama, United States
United States, California
California Professional Research
Newport Beach, California, United States
San Diego Sexual Medicine
San Diego, California, United States
United States, Connecticut
Connecticut Clinical Research
Middlebury, Connecticut, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
United States, Michigan
Michigan Institute of Urology
Saint Clair Shores, Michigan, United States
United States, Nebraska
Quality Clinical Research
Omaha, Nebraska, United States
United States, New Jersey
Premier Urology Associates
Lawrenceville, New Jersey, United States
United States, New York
University Urology
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
United States, North Carolina
PMG Research of Wilmington
Winston-Salem, North Carolina, United States
United States, Ohio
Tristate Urologic Services
Cincinnati, Ohio, United States
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States
Canada, Ontario
St. Joseph's Healthcare
London, Ontario, Canada
Private Practice and Clinical Research
North Bay, Ontario, Canada
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01665599     History of Changes
Other Study ID Numbers: 000023
First Submitted: August 1, 2012
First Posted: August 15, 2012
Results First Submitted: July 3, 2017
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents