General Information

Vogelxo is a topical gel formulation of testosterone. Endogenous androgens, including testosterone, are responsible for the normal growth and development of the primary and secondary male sexual characteristics.

Vogelxo is specifically indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).

Mechanism of Action

Vogelxo is a topical gel formulation of 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. These effects include the growth and maturation of the prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening and alterations in body musculature and fat distribution.

Side Effects

Adverse effects associated with the use of Vogelxo may include, but are not limited to, the following:

• Application site reactions
• Increased hematocrit

Dosing/Administration

Vogelxo is supplied as a gel for topical administration. The recommended starting dose for adult males is 50 mg of testosterone (one tube or one packet or four pump actuations) applied topically once daily at approximately the same time each day. It should be applied to clean, dry, intact skin of the shoulders and/or upper arms. Do not apply Vogelxo to the genitals or abdomen. If morning predose serum testosterone concentration is below the normal range, increase dose to 100 mg. Predose serum testosterone concentration should be assessed periodically. Patients should wash hands with soap and water immediately after applying Vogelxo and cover application site(s) with clothing after gel has dried.

Clinical Trial Results

FDA Approval

The FDA approval was based on a randomized multicenter, multi-dose, active and placebo controlled 90-day study in 406 adult males with morning testosterone levels ≤300 ng/dL. The study was double-blind for the doses of testosterone gel and placebo, but open label for the non­scrotal testosterone transdermal system. During the first 60 days, subjects were evenly randomized to testosterone gel 50 mg, testosterone gel 100 mg, placebo gel or testosterone transdermal system. At Day 60, subjects receiving testosterone gel were maintained at the same dose or were titrated up or down within their treatment group based on 24-hour averaged serum testosterone concentration levels obtained on Day 30. Of 192 hypogonadal men who were appropriately titrated with testosterone gel and who had sufficient data for analysis, 74 percent achieved an average serum testosterone level within the normal range (300 to 1,000 ng/dL) on treatment Day 90.