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

Primary Purpose

Adult Male Hypogonadism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Testosterone gel (FE 999303)
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:

  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

Sites / Locations

  • Medical Affiliated Research Cente
  • California Professional Research
  • San Diego Sexual Medicine
  • Connecticut Clinical Research
  • South Florida Medical Research
  • Michigan Institute of Urology
  • Quality Clinical Research
  • 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 999303)

Arm Description

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.

Outcomes

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
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
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)
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)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
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)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
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)
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Tmax
A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Cmax
A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Cave
A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Cmin
A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Tmin
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
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.
Change From Baseline in the Multidimensional Assessment 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 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
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.

Full Information

First Posted
August 1, 2012
Last Updated
September 25, 2017
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01665599
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 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 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.

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
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone gel (FE 999303)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Testosterone gel (FE 999303)
Primary Outcome Measure Information:
Title
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Description
The data were presented using descriptive statistics. No statistical analysis was performed.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Description
The data were presented using descriptive statistics. No statistical analysis was performed.
Time Frame
Day 1
Title
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Description
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Description
A validated LC/MS/MS method was used to determine the levels of DHT.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of DHT Measuring Tmax
Description
A validated LC/MS/MS method was used to determine the levels of DHT.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of DHT Measuring Cmax
Description
A validated LC/MS/MS method was used to determine the levels of DHT.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of DHT Measuring Cave
Description
A validated LC/MS/MS method was used to determine the levels of DHT.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of DHT Measuring Cmin
Description
A validated LC/MS/MS method was used to determine the levels of DHT.
Time Frame
Day 1; Day 90
Title
Pharmacokinetics of DHT Measuring Tmin
Description
A validated LC/MS/MS method was used to determine the levels of DHT.
Time Frame
Day 1; Day 90
Title
Change From Baseline in the International Index of Erectile Dysfunction (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 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.
Time Frame
Day 91
Title
Change From Baseline in the Multidimensional Assessment 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 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
Day 91
Title
Change From Baseline in the SF-12 Health 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 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.
Time Frame
Day 91

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: 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
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 Cente
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
Quality Clinical Research
City
Omaha
State/Province
Nebraska
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 Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

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