FDA Approved Drugs » 2012
Medical Areas: Endocrinology | Urology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Teva Pharmaceutical
Approval Status: Approved February 2012
Treatment Area: hypogonadism
Bio-T-Gel is a clear, colorless hydroalcoholic gel containing testosterone. Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the
normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Testosterone gel delivers amounts of testosterone that approximate normal concentrations seen in healthy men.
Bio-T-Gel was specifically approved for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
Bio-T-Gel is supplied as a gel for topical administration. The recommended dose is 50 mg of testosterone applied topically once daily in the morning to dry, intact skin on the shoulders and upper arms. The dose can be adjusted between a minimum of 50 mg of testosterone and a maximum of 100 mg of testosterone.
FDA ApprovalThe FDA approval of Bio-T-Gel was based on a multi-center, randomized, parallel-group, active-controlled, 180 day
trial in 227 hypogonadal men. The study was conducted in 2 phases. During the Initial Treatment Period (Days 1 to 90), 73 subjects were randomized to testosterone gel 5 g daily, 78 subjects to testosterone gel 10 g daily, and 76 subjects to a non-scrotal testosterone transdermal system. The study was double-blind for dose of testosterone gel but open-label for active control. Subjects who were originally randomized to
testosterone gel and who had single-sample serum testosterone levels above or below the normal range on Day 60 were titrated to 7.5 g daily on Day 91. During the Extended Treatment Period (Days 91 to 180), 51 subjects continued on testosterone gel 5 g daily, 52 subjects continued on testosterone gel 10 g daily, 41 subjects continued on a non-scrotal testosterone transdermal system (5 mg daily), and 40 subjects received testosterone gel 7.5 g daily. Mean peak, trough and average serum testosterone concentrations within the normal range (298 to 1043 ng/dL) were achieved on the first day of treatment with doses of 5 g and 10 g. In subjects continuing on testosterone gel 5 g and 10 g, these mean testosterone levels were maintained within the normal range
for the 180-day duration of the original study. Testosterone concentrations were maintained as long as the subject continued to properly apply the prescribed
testosterone gel treatment.
Adverse events associated with the use of Bio-T-Gel may include, but are not limited to, the following:
Bio-T-Gel is a clear, colorless hydroalcoholic gel containing testosterone. Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations. Testosterone gel delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal concentrations seen in healthy men. Testosterone gel provides continuous transdermal delivery of testosterone for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen.
For additional information regarding Bio-T-Gel or hypogonadism, please visit the Teva web page.
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