This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
AccuMed Research Associates
Garden City, New York, United States
Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.
Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.
Time frame: From Baseline to Day 43
Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13
Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13
Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13
Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
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The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
The data were presented using descriptive statistics for this outcome.
Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Frequency of Adverse Events (AEs)
The data were presented using descriptive statistics for this outcome.
Time frame: From Baseline to Day 43