Table 4 below summarizes the testosterone concentration data in the patients who completed 120 days. By day 120, average serum testosterone concentration was within normal range for 67% of those who titrated down on the 30 mg dose, 89% of those on the 60 mg dose, 86% of those who titrated up to 90 mg and 70% of those who titrated up to the 120 mg dose. Of the 135 patients who completed the 120 day treatment, 123 patients did so with no deviation from the protocol. On Day 90 of the trial, patients were maintained at the same dose, or were titrated up or down, based on their 24 hour average serum testosterone concentration measured on Day 60. On Day 45 of the trial, patients were maintained at the same dose, or were titrated up or down, based on their 24 hour average serum testosterone concentration measured on Day 15. During the initial AXIRON treatment period (Days 1-15) 143 patients were treated with 60 mg of testosterone daily.
One pump of solution (30 mg of testosterone) should be applied to clean, dry skin of each underarm and allowed to dry. This medication is used to replace testosterone in men who have conditions caused by low testosterone levels. Testosterone topical solution belongs to the class of medications called androgens (male hormones). No serious adverse reactions to Axiron were reported during either the 120 day trial, or the extension to 180 days. Testosterone may decrease blood glucose levels and less insulin may be required in diabetic patients. Doctors prescribe these drugs to adult males who for some reason, whether a physical condition or a result of aging, are lacking normal testosterone levels. According to research, men with low testosterone levels are more likely to have chronic diseases such as high blood pressure and type II diabetes.
What are the possible side effects of AXIRON? Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AXIRON has been applied. AXIRON is not meant for use in women. Never give AXIRON to anyone else, even if they have the same symptoms you have. AXIRON is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Your healthcare provider will test your blood before you start and while you are taking AXIRON.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. More frequent monitoring of INR and prothrombin time is recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during postapproval use of AXIRON. Following the 120 day study, seventy-one (71) patients entered a two-month extension study with AXIRON.
The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

Gender: Female

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