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A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

Primary Purpose

Adult Male Hypogonadism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Testosterone Gel (FE 999093)
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Male Hypogonadism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Affiliated Research Center
  • California Professional Research
  • San Diego Sexual Medicine
  • Connecticut Clinical Research
  • South Florida Medical Research
  • Michigan Institute of Urology
  • Premier Urology Associates
  • University Urology
  • Premier Medical Group of the Hudson Valley
  • PMG Research of Wilmington
  • Tristate Urologic Services
  • Omega Medical Research
  • Coastal Carolina Research Center
  • Carolina Urologic Research Center
  • Clinical Research Associates
  • Urology Clinics of North Texas
  • St. Joseph's Healthcare
  • Private Practice and Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Testosterone gel (FE 999093)

Arm Description

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.

Outcomes

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
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.
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
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 1-10 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
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
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 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
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
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
The data were presented using descriptive statistics.
Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
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
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
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
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
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.

Full Information

First Posted
October 4, 2012
Last Updated
September 19, 2017
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01703741
Brief Title
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
Official Title
A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Male Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone gel (FE 999093)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Testosterone Gel (FE 999093)
Primary Outcome Measure Information:
Title
Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
Description
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.
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)
Secondary Outcome Measure Information:
Title
Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.
Description
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.
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)
Title
Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire
Description
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 1-10 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.
Time Frame
At Month 6
Title
Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire
Description
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.
Time Frame
At Month 6
Title
Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire
Description
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 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.
Time Frame
At Month 6
Title
Domain Scores for the Short Form-12 (SF-12) Questionnaire
Description
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.
Time Frame
At Month 6
Title
Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
Description
The data were presented using descriptive statistics.
Time Frame
At Month 3
Title
Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
Description
The data were presented using descriptive statistics.
Time Frame
At Month 6
Title
Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Description
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 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)
Title
Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone
Description
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 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)
Title
Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Description
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 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)
Title
Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Description
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 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)
Title
Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Description
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 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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
California Professional Research
City
Newport Beach
State/Province
California
Country
United States
Facility Name
San Diego Sexual Medicine
City
San Diego
State/Province
California
Country
United States
Facility Name
Connecticut Clinical Research
City
Middlebury
State/Province
Connecticut
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Michigan Institute of Urology
City
Saint Clair Shores
State/Province
Michigan
Country
United States
Facility Name
Premier Urology Associates
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
University Urology
City
New York
State/Province
New York
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
PMG Research of Wilmington
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Tristate Urologic Services
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Clinical Research Associates
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
St. Joseph's Healthcare
City
London
State/Province
Ontario
Country
Canada
Facility Name
Private Practice and Clinical Research
City
North Bay
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

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