How does androgen gel come?

Androgen Gel Formulations and Administration

Androgen gel comes in various transdermal formulations including different concentrations (1%, 1.62%, 2%), delivery systems (packets, metered-dose pumps), and application methods designed for specific body sites. 1

Available Formulations

• Testosterone gel is available in several transdermal preparations:
  • AndroGel 1% - 25 mg in 2.5-g packet (50-100 mg/day dosing) 1
  • AndroGel 1.62% - 20.25 mg in 1.25-g packet (20.25-81 mg/day dosing) 1
  • Axiron 2% solution - metered-dose pump (30 mg per actuation, 30-120 mg/day) 1
  • Fortesta 2% gel - metered-dose pump (10 mg per actuation, 10-70 mg/day) 1
  • Testim 1% gel - 50 mg in 5-g packet (50-100 mg/day) 1
  • Testogel 1% gel - 50 mg in 5-g packet (50-100 mg/day) 1

Application Methods

• Testosterone gel is designed for specific application sites:
  • Most formulations are applied to the skin of the back, abdomen, upper thighs, and upper arms 1, 2
  • Axiron 2% solution is specifically designed for application to the axilla (underarm) using an applicator 1
  • Fortesta 2% gel is specifically applied to the front and inner thighs 1

Administration Characteristics

• Gel preparations dry quickly when applied to the skin surface 1
• Application should be to clean, dry, intact skin 2
• The gel should be allowed to dry completely before dressing (typically less than 5 minutes) 2, 3
• Patients should avoid swimming, showering, or washing the application site for a minimum of 2 hours after application 2

Advantages and Disadvantages

Advantages:

• Easy application with good skin tolerability 1
• Produces normal serum testosterone concentrations 1
• Provides stable day-to-day testosterone levels compared to injections 1
• Avoids discomfort of intramuscular injections 1
• Patients typically find them convenient 1

Disadvantages:

• Potential for transfer to partners or children through skin-to-skin contact 1, 2
• Can be more expensive than injectable formulations 1
• Variable absorption from gels can provide inconsistent testosterone replacement in some patients 1
• Requires daily application 1

Safety Considerations

• Risk of secondary exposure requires precautions:
  • Application sites should be covered with clothing after the gel has dried 2
  • Patients should wash hands thoroughly with soap and water immediately after application 2
  • Children and women should avoid contact with unwashed or unclothed application sites 2
  • Prior to skin-to-skin contact, application sites should be washed thoroughly 2

Monitoring

• Testosterone levels should be tested 2-3 months after treatment initiation or dose changes 1
• For patients on stable doses, monitoring every 6-12 months is typically sufficient 1
• Serum testosterone levels typically reach steady state within 1-2 days of daily application 3

Clinical Efficacy

• Transdermal testosterone gel applications can restore testosterone levels to mid-normal physiological range (14-17.5 nmol/L) within 24 hours 4
• In clinical trials, 81.6-82.5% of patients achieved eugonadal testosterone levels with 1.62% gel formulations 5