Bioequivalence study comparing AndroForte 5 (Registered Trademark (R)) and Testogel (R) 1%
An open-label, phase 2, single centre, randomised, crossover design bioequivalence study of AndroForte (R) 5 Compared With Testogel (R) 1% in Hypogonadal Men
Lawley Pharmaceuticals
16 participants
Dec 1, 2010
Interventional
Conditions
Summary
The study will determine if AndroForte (R) 5 (testosterone cream) is bioequivalent to Testogel (R) 1% (testosterone gel) for the treatment of men with low testosterone levels. Participants will apply the cream or gel to their torso for 30 days during each treatment period and at the start and finish of each of the treatment periods, participants will provide blood samples at pre-determined time points for the measurement of blood testosterone levels. This study aims to establish that AndroForte (R) 5 is equally effective as Testogel (R) 1% (considered to be the standard comparator for transdermal testosterone worldwide), in increasing the testosterone levels in men with low testosterone to within the normal circulating range.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
AndroForte 5 white oil-in-water cream containing testosterone 50mg/mL 2ml of cream to be topically applied to torso once daily for 30 days. Washout period 7 - 10 days between crossover treatments
Locations(1)
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ACTRN12610000834055