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

Phase 3

Completed

• Conditions: Adult Male Hypogonadism
• Interventions: Drug: Testosterone gel (FE 999303)

• Registration Number: NCT01665599
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-15
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Disposition First Submitted: 2014-04-08
• Disposition First Submitted QC: 2014-04-08
• Disposition First Posted: 2014-05-02
• Results First Submitted: 2017-07-03
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-19
• Results First Posted: 2017-09-20
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone gel (FE 999303)	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.

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL	Day 90	The data were presented using descriptive statistics. No statistical analysis was performed.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)	Day 1; Day 90	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 Minimum Observed Concentration (Tmin)	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of total testosterone.
Pharmacokinetics of DHT Measuring Tmax	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Cmax	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of DHT.
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL	Day 1	The data were presented using descriptive statistics. No statistical analysis was performed.
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of total testosterone.
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of total testosterone.
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Cave	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)	Day 1; Day 90	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)	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of total testosterone.
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire	Day 91	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 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.
Pharmacokinetics of DHT Measuring Cmin	Day 1; Day 90	A validated LC/MS/MS method was used to determine the levels of DHT.
Pharmacokinetics of DHT Measuring Tmin	Day 1; Day 90	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	Day 91	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 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 SF-12 Health Questionnaire	Day 91	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.

Trial Locations

Locations (19)

Private Practice and Clinical Research; 🇨🇦 North Bay, Ontario, Canada

California Professional Research; 🇺🇸 Newport Beach, California, United States

Medical Affiliated Research Cente; 🇺🇸 Huntsville, Alabama, United States

San Diego Sexual Medicine; 🇺🇸 San Diego, California, United States

University Urology; 🇺🇸 New York, New York, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Poughkeepsie, New York, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States

PMG Research of Wilmington; 🇺🇸 Winston-Salem, North Carolina, United States

Tristate Urologic Services; 🇺🇸 Cincinnati, Ohio, United States

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

Quality Clinical Research; 🇺🇸 Omaha, Nebraska, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Coastal Carolina Research Center; 🇺🇸 Mount Pleasant, South Carolina, United States

Clinical Research Associates; 🇺🇸 Nashville, Tennessee, United States

Michigan Institute of Urology; 🇺🇸 Saint Clair Shores, Michigan, United States

Connecticut Clinical Research; 🇺🇸 Middlebury, Connecticut, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

St. Joseph's Healthcare; 🇨🇦 London, Ontario, Canada

Premier Urology Associates; 🇺🇸 Lawrenceville, New Jersey, United States