What is the role of testosterone therapy in women?

From the FDA Drug Label

5.7 Use in Women Due to the lack of controlled evaluations in women and potential virilizing effects, testosterone gel, 1. 62% is not indicated for use in women [see Contraindications (4) and Use in Specific Populations (8.1, 8.2)]. The use of testosterone therapy in women is not indicated due to the lack of controlled evaluations and potential virilizing effects. 1

From the Research

Testosterone therapy in women should be used to treat hypoactive sexual desire disorder (HSDD) with a recommended approach involving low-dose testosterone preparations, specifically transdermal forms, as evidenced by the most recent and highest quality study 2.

Key Considerations

• The International Society for the Study of Women's Sexual Health recommends systemic transdermal testosterone for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems 2.
• Current available research supports a moderate therapeutic benefit of testosterone therapy in women with HSDD, with safety data showing no serious adverse events with physiologic testosterone use, although long-term safety has not been established 2, 3.
• Before initiation of therapy, clinicians should provide an informed consent, and shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks 2.

Treatment Approach

• Treatment should start at the lowest effective dose and be titrated based on symptoms and serum testosterone levels, aiming to maintain levels within the upper range of normal for premenopausal women (15-70 ng/dL) 2, 4.
• Regular monitoring is essential, with testosterone levels checked at 3-6 month intervals during the first year and annually thereafter, and patients should be monitored for potential side effects including acne, hirsutism, voice deepening, and lipid changes 2, 5.
• Therapy should be discontinued if benefits aren't observed within 6 months, and testosterone therapy works by improving libido, energy, and mood through direct effects on brain receptors, increasing muscle mass, and enhancing overall well-being 2, 6.

Formulations and Dosing

• Common options include testosterone gels (0.5-1% applied daily), creams (0.5-1% applied daily), or patches (150-300 mcg/day), with the 300-microg/d testosterone patch being a specifically studied and effective dose for HSDD in postmenopausal women 4, 3.
• For some women, compounded testosterone preparations at 0.5-2 mg daily may be prescribed, but government-approved transdermal male formulations can be used cautiously with dosing appropriate for women, and patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range 2.