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A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

Primary Purpose

Adult Male Hypogonadism

Status
Completed
Phase
Phase 3
Locations
United States
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:

  • Males between 18-75 years of age
  • Two fasting serum testosterone levels <300 ng/dL

Exclusion Criteria:

  • Previous use of the study drug
  • History of prostate or breast cancer
  • Prostate-Specific Antigen (PSA) ≥3 ng/mL
  • Subject is sexually active and not willing to use adequate contraception

Sites / Locations

  • Investigational site
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  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Testosterone gel (FE 999303)

Arm Description

Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.

Outcomes

Primary Outcome Measures

The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.

Secondary Outcome Measures

The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
The data were presented using descriptive statistics. No statistical analysis was performed.
Change From Baseline in International Index of Erectile Function (IIEF) Score
Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were: 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 Multidimensional Assessment of Fatigue (MAF) Score
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 (categorical in nature) are scored from 1-4. The scores are 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. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue).
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains: PCS: Physical Functioning (2 items, questions 2-3) Role-Physical (2 items, questions 4-5) Bodily Pain (1 item, question 8) General Health (1 item, question 1) MCS: Vitality (1 item, question 10) Social Functioning (1 item, question 12) Role-Emotional (2 items, questions 6-7) Mental Health (2 items, questions 9 and 11) PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health.
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.

Full Information

First Posted
May 19, 2014
Last Updated
September 25, 2017
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02149264
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
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 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (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, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.

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
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone gel (FE 999303)
Arm Type
Experimental
Arm Description
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
Intervention Type
Drug
Intervention Name(s)
Testosterone gel (FE 999303)
Primary Outcome Measure Information:
Title
The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Description
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
Time Frame
At Day 90
Secondary Outcome Measure Information:
Title
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Description
The data were presented using descriptive statistics. No statistical analysis was performed.
Time Frame
At 14, 35 and 56
Title
Change From Baseline in International Index of Erectile Function (IIEF) Score
Description
Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were: 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
At Days 35 and 90
Title
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
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 (categorical in nature) are scored from 1-4. The scores are 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. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue).
Time Frame
At Days 35 and 90
Title
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
Description
Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains: PCS: Physical Functioning (2 items, questions 2-3) Role-Physical (2 items, questions 4-5) Bodily Pain (1 item, question 8) General Health (1 item, question 1) MCS: Vitality (1 item, question 10) Social Functioning (1 item, question 12) Role-Emotional (2 items, questions 6-7) Mental Health (2 items, questions 9 and 11) PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health.
Time Frame
At Days 35 and 90
Title
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
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 and dihydrotestosterone.
Time Frame
Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Title
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Time Frame
Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Title
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Time Frame
Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Title
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Time Frame
Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
Title
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Description
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Time Frame
Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90

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 fasting serum testosterone levels <300 ng/dL Exclusion Criteria: Previous use of the study drug History of prostate or breast cancer Prostate-Specific Antigen (PSA) ≥3 ng/mL Subject is sexually active and not willing to use adequate contraception
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
Investigational site
City
Anniston
State/Province
Alabama
Country
United States
Facility Name
Investigational site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Investigational site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Investigational site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Investigational site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Investigational site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Investigational site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Investigational site
City
Mishawaka
State/Province
Indiana
Country
United States
Facility Name
Investigational site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Investigational site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
Investigational site
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
Investigational site
City
Lawrence Township
State/Province
New Jersey
Country
United States
Facility Name
Investigational site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Investigational site
City
New York
State/Province
New York
Country
United States
Facility Name
Investigational site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Investigational site
City
Purchase
State/Province
New York
Country
United States
Facility Name
Investigational site
City
Bala-Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Investigational site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Investigational site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Investigational site
City
Webster
State/Province
Texas
Country
United States
Facility Name
Investigational site
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

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