Testosterone

Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.

12.1 Mechanism of Action 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 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, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.

Clinical clearance of Testosterone (Androgen) relies on local esterase/enzymatic cleavage of testosterone with minimal hepatic cytochrome burden with a Predominantly local clearance at target epithelium for Testosterone half-life; patients absorbing at < 5% transdermal or mucosal systemic uptake from Testosterone bioavailability typically observe target onset around initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (testosterone).

FDA clinical labeling for Testosterone restricts administration in testosterone topical solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate .; testosterone topical solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding.; testosterone topical solution may cause fetal harm when administered to a pregnant woman. across 20.25 mg/1.25g Gel, Metered, 20.25 mg/1.25g Gel, 50 mg/5g Gel, 16.2 mg/g Gel, 5.5 mg/.122g Gel, Metered, with self-reported patient tracking dominated by headache (11.5% of reports), diarrhea (10.2% of reports), nausea (8.4% of reports).