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

A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

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.

Study Overview

• Status: Completed
• Conditions: Adult Male Hypogonadism
• Intervention / Treatment: Drug: Testosterone gel (FE 999303)

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • St. Joseph's Healthcare
    • North Bay, Ontario, Canada
      • Private Practice and Clinical Research
• United States
  • Alabama
    • Huntsville, Alabama, United States
      • Medical Affiliated Research Cente
  • California
    • Newport Beach, California, United States
      • California Professional Research
    • San Diego, California, United States
      • San Diego Sexual Medicine
  • Connecticut
    • Middlebury, Connecticut, United States
      • Connecticut Clinical Research
  • Florida
    • Aventura, Florida, United States
      • South Florida Medical Research
  • Michigan
    • Saint Clair Shores, Michigan, United States
      • Michigan Institute of Urology
  • Nebraska
    • Omaha, Nebraska, United States
      • Quality Clinical Research
  • New Jersey
    • Lawrenceville, New Jersey, United States
      • Premier Urology Associates
  • New York
    • New York, New York, United States
      • University Urology
    • Poughkeepsie, New York, United States
      • Premier Medical Group of the Hudson Valley
  • North Carolina
    • Winston-Salem, North Carolina, United States
      • PMG Research of Wilmington
  • Ohio
    • Cincinnati, Ohio, United States
      • Tristate Urologic Services
  • Rhode Island
    • Warwick, Rhode Island, United States
      • Omega Medical Research
  • South Carolina
    • Mount Pleasant, South Carolina, United States
      • Coastal Carolina Research Center
    • Myrtle Beach, South Carolina, United States
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States
      • Clinical Research Associates
  • Texas
    • Dallas, Texas, United States
      • Urology Clinics of North Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1; Day 90
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.	Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
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.	Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
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.	Day 1; Day 90
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmax	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmax	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Pharmacokinetics of DHT Measuring Cave	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmin	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmin	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
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.	Day 91
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.	Day 91
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.	Day 91

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 000023