This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.
Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
40 mg testosterone gel 2%
Quality of Life Medical & Research Center
Tucson, Arizona, United States
Connecticut Clinical Research
Middlebury, Connecticut, United States
Compass Research East, LLC
Oviedo, Florida, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, United States
Time to Target Eugonadal Range
The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.
Time frame: 24 hours
Time to Steady State (SS)
Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.
Time frame: 14 days
Gel Drying Time
Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.
Time frame: 1 day; drying time measured following gel application on Day 14
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Men's Health Boston
Brookline, Massachusetts, United States
Tory Internal Medicine, PC
Troy, Michigan, United States
Matrix Research, LLC
Greer, South Carolina, United States
Cetero Research
San Antonio, Texas, United States