What are the guidelines for testosterone therapy in women?

Guidelines for Testosterone Therapy in Women

Testosterone therapy in women should only be considered for the treatment of hypoactive sexual desire disorder (HSDD) after ruling out other causes, using transdermal formulations to maintain physiologic levels, and with appropriate monitoring for adverse effects. 1

Indications for Testosterone Therapy in Women

Testosterone therapy in women is primarily indicated for:

• Hypoactive sexual desire disorder (HSDD) not related to modifiable factors 1
• Low libido and sexual dysfunction in postmenopausal women who are adequately estrogenized 2
• Sexual interest/desire disorders in women with symptoms of androgen insufficiency 2

It's important to note that testosterone therapy for women is not FDA-approved in the United States, making all use "off-label" 1.

Pre-Treatment Assessment

Before initiating testosterone therapy:

1. Rule out other causes of sexual dysfunction:

   • Relationship issues
   • Mental health problems
   • Medication side effects
   • Other medical conditions

2. Laboratory testing:

   • Baseline total testosterone level (not for diagnosis but for monitoring) 1
   • Estradiol levels (especially in postmenopausal women)
   • Measure serum estradiol in patients presenting with breast symptoms or gynecomastia 3

3. Risk assessment:

   • Cardiovascular risk factors
   • Breast cancer risk
   • Liver function

Dosing and Administration

Recommended Formulations:

• Transdermal testosterone is the preferred route of administration 1
  • Use male formulations cautiously with dosing appropriate for women
  • Target testosterone levels in the physiologic premenopausal range

Formulations to Avoid:

• Oral testosterone preparations should be avoided due to potential hepatotoxicity 4
• Compounded products cannot be recommended due to lack of efficacy and safety data 1
• Alkylated oral testosterone should not be prescribed due to liver toxicity risk 3

Monitoring During Treatment

Regular follow-up is essential:

1. Initial follow-up: 3-6 months after starting therapy

   • Assess symptom improvement
   • Monitor testosterone levels
   • Evaluate for side effects

2. Ongoing monitoring:

   • Total testosterone levels (maintain in physiologic premenopausal range) 1
   • Signs of androgen excess (acne, hirsutism, voice changes)
   • Lipid profile (especially with oral formulations) 5

3. Long-term surveillance:

   • Breast examination
   • Cardiovascular risk assessment
   • Liver function tests

Potential Benefits

Women may experience improvements in:

• Sexual desire and arousal 2
• Sexual satisfaction and frequency 2
• Sense of well-being 4
• Energy levels 4
• Bone mass 4

Potential Risks and Side Effects

Common Side Effects:

• Mild and reversible acne 5
• Hirsutism 5
• Changes to lipid profile (with oral, but not transdermal testosterone) 5

Potential Concerns:

• Virilization (with supraphysiologic doses) 4
• Hepatotoxicity (primarily with oral formulations) 4
• Unclear long-term effects on breast cancer risk 5
• Unclear long-term cardiovascular effects 5

Special Considerations

Premenopausal vs. Postmenopausal Women:

• Most evidence supports use in postmenopausal women 1
• Limited data supports use in late reproductive age premenopausal women 1

Surgical vs. Natural Menopause:

• Women with surgical menopause (oophorectomy) often experience more severe androgen deficiency 6
• These women may benefit more significantly from testosterone therapy 6

Transgender and Gender-Diverse Individuals:

• Testosterone therapy is used in transgender men and some non-binary individuals assigned female at birth 3
• Standard doses aim to achieve serum testosterone in the typical cisgender male reference range 3
• Effects include deeper voice, body/facial hair growth, menstrual suppression, increased libido, clitoral growth, increased muscle mass, and reduced fat mass 3
• Low-dose testosterone may be used for gradual effects in non-binary individuals 3

Contraindications

Testosterone therapy should not be used in women with:

• Active or history of hormone-sensitive cancers
• Uncontrolled cardiovascular disease
• Severe liver disease
• Pregnancy or breastfeeding
• Untreated polycythemia

Informed Consent

Given the off-label nature of testosterone therapy for women, thorough informed consent is essential, including:

• Discussion of limited FDA approval status
• Potential benefits and risks
• Limitations of long-term safety data
• Alternative treatment options

The clinical decision to use testosterone therapy in women requires careful consideration of benefits versus risks, with monitoring to maintain physiologic testosterone levels and minimize adverse effects.