Comparison of testosterone replacement therapy preparations

Testosterone formulation

Initial dosing

Pharmacokinetic profile

Advantages

Formulation specific adverse effects

Buccal

1 tablet (30 mg) applied every 12 hours

Serum T peak in 10–12 hours and drop 2–4 hours after product removal

Mimics circadian T rhythm; quick reversal

Gum disorders (irritation, inflammation, gingivitis)

Nasal

1 actuation in each nostril 3 times a day (33 mg/day)

Serum T peak in 40 minutes and t1/2 is 10–100 minutes

Non-invasive; no concerns for transfer to others

Rhinorrhea; nose bleeds; nasal discomfort

Subdermal

150–450 mg implanted SQ every 3–6 months

Serum T peak at 1 month and t1/2 of 2.5 months

Dosing frequency; no potential for transfer; improved compliance

Fibrosis; bleeding and infection at insertion site; pellet extrusion

Transdermal patch

4 mg/day applied at night

Serum T peaks at 8.2 hours and t1/2 is 1.3 hours

Mimics T circadian rhythm; easy application

Skin blistering; pruritus; irritation

Gel AndroGel®

50 mg applied to shoulders, upper arms, or abdomen once daily in the morning

Serum T peaks 16–22 hours and absorbed continuously throughout the 24-hour dosing period

Several areas for application; easy application

Increase PSA level; acne, application site reaction

Gel Fortesta®

40 mg applied to thighs once daily in the morning

Serum T peaks 2–4 hours after application

Metered dose pump allows 10 mg adjustments; easy application

Mild to moderate skin reactions at application site

Gel Testim®

50 mg applied to shoulders or upper arms once daily in the morning

Serum T peaks 24 hours and absorbed continuously throughout the 24-hour dosing period

Easy application

Skin reactions at application site

Gel Vogelxo®

50 mg applied to shoulders or upper arms once daily at the same time

Absorbed continuously over the 24-hour period; achieves therapeutic levels after one dose

Less skin irritation than transdermal patches

Skin irritation at site of application

Solution Axiron®

60 mg applied to the underarms once daily in the morning

Serum T peaks 2–4 hours and remains in therapeutic range throughout 24-hour period

Use of applicator to decrease risk of transfer to others

Skin irritation at site of application; nasopharyngitis

IM testosterone cypionate

50–400 mg every 2–4 weeks

Supratherapeutic T levels 4–5 days after dose and subtherapeutic day 14

Less frequent dosing than topical applications

Inflammation and pain at injection site

IM testosterone enanthate

50–400 mg every 2–4 weeks

Supratherapeutic T levels 36–48 hours post-dose and subtherapeutic 3–4 weeks

Less frequent dosing than topical applications

Inflammation and pain at injection site

IM testosterone undecanoate

750 mg once, 750 mg 4 weeks later, then 750 mg every 10 weeks

Serum T peaks by day 7 and subtherapeutic by week 10 after 3 doses

Least frequent dosing of all IM formulations

POME/anaphylaxis; inflammation and pain at injection site

T, testosterone; t1/2, half-life; SQ, subcutaneous; PSA, prostate-specific antigen; REMS, risk evaluation and mitigation strategies; IM, intramuscular; POME, pulmonary oil microembolism.

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