Vogelxo contains testosterone, a Schedule III controlledsubstance in the Controlled Substances Act. However, in the 100 mg dose group, 2.3% and 2.8% ofpatients had a clinically notable increase in hemoglobin ( ≥ 19 g/dL) orhematocrit ( ≥ 58%), respectively, compared to 1.0% and 1.5% of patientsin the placebo group, respectively. In one foreign Phase 3 trial, onesubject discontinued due to a skin-related adverse event. Because clinical trials are conducted under widelyvarying conditions, adverse reaction rates observed in the clinical trials of adrug cannot be directly compared to rates in the clinical trials of anotherdrug and may not reflect the rates observed in practice. Each tube or packet contains 50 mgtestosterone in 5 g of gel. Vogelxo is supplied in unit-dose tubes in cartons of 30and unit-dose packets in cartons of 30. Each tube or packetprovides 50 mg testosterone in 5 g of gel. This has proven contentious, with the Court of Arbitration for Sport suspending the IAAF policy due to insufficient evidence of a link between high androgen levels and improved athletic performance. The most common route of administration for testosterone is by intramuscular injection. Testosterone pellet implants are approved for use in postmenopausal women in the United Kingdom. Other androgenic side effects, such as weight gain, pattern hair loss, and voice deepening, were also reported in some trials, but were excluded from analyses due to insufficient data. The changes were more pronounced with oral testosterone undecanoate than with parenteral routes, such as transdermal testosterone. In addition, testosterone binds to and activates membrane androgen receptors (mARs) such as GPRC6A and ZIP9. Testosterone therapy is sometimes combined with an aromatase inhibitor for men with secondary hypogonadism who wish to conceive children with their partners. Aromatase inhibitors like anastrozole prevent the conversion of testosterone into estradiol by aromatase. In addition to the prevention of testosterone conversion into DHT, 5α-reductase inhibitors also prevent the formation of neurosteroids like 3α-androstanediol from testosterone, and this may have neuropsychiatric consequences in some men. For instance, growth of body and facial hair and penile growth induced by testosterone may be inhibited by 5α-reductase inhibitors, and this could be considered undesirable in the context of, for instance, puberty induction. Androgens like testosterone are teratogens and are known to cause fetal harm, such as producing virilization and ambiguous genitalia. In contrast to the case of testosterone, such potentiation occurs to a reduced extent or not at all with most synthetic AAS (as well as with DHT), and this is primarily responsible for the dissociation of anabolic and androgenic effects with these agents. Testosterone is also potentiated via transformation by 5α-reductase into the more potent androgen DHT in so-called androgenic tissues such as the prostate gland, seminal vesicles, skin, and hair follicles. Antiandrogens like cyproterone acetate, spironolactone, and bicalutamide can block the androgenic and anabolic effects of testosterone. Men with known or suspected prostate or breast cancershould not use Vogelxo see CONTRAINDICATIONS and WARNINGS ANDPRECAUTIONS. In addition to discontinuation of the drug, diuretic therapy may berequired. Androgens, including Vogelxo, may promote retention ofsodium and water. Nonetheless, patients should be instructed to report any signsor symptoms of hepatic dysfunction (e.g., jaundice). If testosterone abuse is suspected, check serumtestosterone concentrations to ensure they are within therapeutic range.However, testosterone levels may be in the normal or subnormal range in menabusing synthetic testosterone derivatives. Some female athletes may have naturally higher levels of testosterone than others, and may be asked to consent to sex verification and either surgery or drugs to decrease testosterone levels. However, it has been reported that AndroGel, a transdermal gel formulation of testosterone, has become the most popular form of testosterone in androgen replacement therapy for hypogonadism in the United States. There are approved testosterone products for women in Australia, where it is considered a drug of dependence, medicines that are subject to misuse and trafficking, and some European countries. Testosterone gel should be promptly discontinued until thecause of virilization has been identified. Changes in insulin sensitivity or glycemic control mayoccur in patients treated with androgens. Because the reactionsare reported voluntarily from a population of uncertain size, it is not alwayspossible to reliably estimate their frequency or establish a causalrelationship to drug exposure. The patient should avoid swimming or showering or washingthe administration site for a minimum of 2 hours after application seeCLINICAL PHARMACOLOGY. In order to prevent transfer to another person, clothingshould be worn to cover the application sites. Hands should be washed thoroughly with soap and waterafter Vogelxo has been applied. Table 2 has specific dosing guidelines for whenthe metered pump is used.
