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A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703741
First Posted: October 10, 2012
Last Update Posted: October 6, 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 multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

Condition Intervention Phase
Adult Male Hypogonadism Drug: Testosterone Gel (FE 999093) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Extension Trial to Evaluate the 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:
  • Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.



Secondary Outcome Measures:
  • Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.


  • Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire [ Time Frame: At Month 6 ]

    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 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.


  • Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire [ Time Frame: At Month 6 ]

    In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions.

    The data were presented using descriptive statistics.


  • Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire [ Time Frame: At Month 6 ]

    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 scores of 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.


  • Domain Scores for the Short Form-12 (SF-12) Questionnaire [ Time Frame: At Month 6 ]

    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 SD 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.


  • Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL [ Time Frame: At Month 3 ]
    The data were presented using descriptive statistics.

  • Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL [ Time Frame: At Month 6 ]
    The data were presented using descriptive statistics.

  • Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.


  • Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.


  • Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.


  • Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.


  • Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) ]

    Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

    The data were presented using descriptive statistics.



Enrollment: 145
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone gel (FE 999093)
Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.
Drug: Testosterone Gel (FE 999093)

  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:

  • Completion of the Phase 3 protocol (NCT01665599)

Exclusion Criteria:

  • Use of another investigational product
  • Use of any medications that could be considered anabolic or interfere with androgen metabolism
  • Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
  • Use of another testosterone product
  • Chronic use of any drug of abuse
  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): NCT01703741


Locations
United States, Alabama
Medical Affiliated Research Center
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, 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: NCT01703741     History of Changes
Other Study ID Numbers: 000077
First Submitted: October 4, 2012
First Posted: October 10, 2012
Results First Submitted: June 29, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 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