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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Medical Affiliated Research Cente
Huntsville, Alabama, United States
California Professional Research
Newport Beach, California, United States
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.
Time frame: Day 90
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
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San Diego Sexual Medicine
San Diego, California, United States
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Middlebury, Connecticut, United States
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Aventura, Florida, United States
Michigan Institute of Urology
Saint Clair Shores, Michigan, United States
Quality Clinical Research
Omaha, Nebraska, United States
Premier Urology Associates
Lawrenceville, New Jersey, United States
University Urology
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
...and 9 more locations
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Time frame: 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.
Time frame: Day 1; Day 90
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
A validated LC/MS/MS method was used to determine the levels of DHT.
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmax
A validated LC/MS/MS method was used to determine the levels of DHT.
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmax
A validated LC/MS/MS method was used to determine the levels of DHT.
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cave
A validated LC/MS/MS method was used to determine the levels of DHT.
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Cmin
A validated LC/MS/MS method was used to determine the levels of DHT.
Time frame: Day 1; Day 90
Pharmacokinetics of DHT Measuring Tmin
A validated LC/MS/MS method was used to determine the levels of DHT.
Time frame: 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: 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.
Time frame: Day 91
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
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.
Time frame: 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.
Time frame: Day 91