What is the recommended protocol for prescribing testosterone (testosterone) therapy to women?

Testosterone Therapy for Women: Prescribing Protocol

Testosterone therapy in women should be limited to carefully selected postmenopausal women with hypoactive sexual desire disorder (HSDD) who have no contraindications, using transdermal preparations at low doses with regular monitoring for adverse effects. 1

Appropriate Indications

• Primary indication: Hypoactive sexual desire disorder (HSDD) with personal distress 2
• Must rule out other causes of low libido before considering testosterone therapy:
  • Physical factors (pain, medications)
  • Psychological factors (depression, relationship issues)
  • Other hormonal imbalances

Patient Selection

• Best candidates:
  • Postmenopausal women (natural or surgical) 1, 2
  • Women with documented low testosterone levels (though testing is limited in accuracy) 2
  • Women already on estrogen therapy (testosterone monotherapy lacks safety data) 2

Contraindications

• Absolute contraindications:
  • Breast or uterine cancer 2
  • Cardiovascular disease 2
  • Liver disease 2
  • Women trying to conceive 3
  • Pregnancy or breastfeeding

Dosing Protocol

1. Formulation selection: Transdermal patches or topical gels/creams are preferred over oral formulations 2

   • Oral testosterone has greater risk of hepatotoxicity and adverse lipid effects 4
   • Custom-compounded products should be used with caution due to inconsistent dosing 2

2. Starting dose: Use lowest effective dose that achieves symptom relief

   • Target testosterone levels in the upper normal range for reproductive-age women 4
   • Avoid supraphysiologic dosing which increases risk of virilization 5, 4

3. Monitoring schedule:

   • Baseline: Complete history, physical exam, lipid panel, liver function tests, mammogram
   • Follow-up: 3 months after initiation, then every 6-12 months 6
   • Monitor testosterone levels to avoid supraphysiologic dosing 2
   • Assess for clinical improvement in sexual function and potential adverse effects

Adverse Effects to Monitor

• Common side effects:

  • Acne and hirsutism (mild and reversible at appropriate doses) 4
  • Voice deepening (may be irreversible)
  • Clitoral enlargement
  • Hair loss

• Potential serious concerns:

  • Lipid profile changes (primarily with oral formulations) 4
  • Hepatotoxicity risk (primarily with oral formulations) 5
  • Unknown long-term risks for cardiovascular disease and breast cancer 1, 2

Duration of Therapy

• Use for shortest time necessary to meet treatment goals 2
• Long-term safety data beyond 2 years is lacking 4, 1
• Reassess benefit vs. risk at each follow-up visit
• Consider drug holidays to reassess need for continued therapy

Patient Counseling

• Discuss realistic expectations for improvement in sexual function
• Emphasize limited FDA approval status for testosterone in women
• Obtain informed consent regarding:
  • Off-label use
  • Limited long-term safety data
  • Potential for virilizing effects
  • Need for regular monitoring

Pitfalls to Avoid

• Using testosterone for non-approved indications (insufficient evidence for bone density, hot flashes, or general well-being) 2
• Prescribing supraphysiologic doses that increase risk of virilization 4
• Using testosterone products formulated for men without appropriate dose adjustment 2
• Neglecting to monitor for adverse effects
• Prescribing without concomitant estrogen therapy (insufficient safety data) 2
• Using alkylated oral testosterone (associated with liver toxicity) 3

By following this protocol, clinicians can appropriately prescribe testosterone therapy to women with HSDD while minimizing risks and maximizing potential benefits.