What are the guidelines for testosterone supplementation in women?

Testosterone Supplementation for Women

Testosterone therapy should be considered for postmenopausal women with hypoactive sexual desire disorder (HSDD) who have completed a biopsychosocial assessment, after excluding modifiable factors like relationship problems, mental health conditions, and medication effects. 1

Indications for Testosterone Therapy

Primary indication: Postmenopausal women with HSDD causing personal distress, where low sexual desire is not primarily related to modifiable factors or comorbidities. 1

• The International Society for the Study of Women's Sexual Health endorses testosterone therapy specifically for postmenopausal women with HSDD, though limited data support use in late reproductive age premenopausal women. 1
• Women must have persistent, unexplained low libido that causes personal distress, potentially accompanied by fatigue and decreased sense of well-being. 2
• Testosterone therapy is not approved by the FDA for women in the United States, making all use off-label. 2, 3

Diagnostic Approach

Do not use total testosterone levels to diagnose HSDD in women. 1

• There are no validated reference ranges for "optimal" testosterone in postmenopausal women, making measured values clinically meaningless for diagnosis. 4
• Baseline total testosterone should be obtained only for monitoring purposes after treatment initiation, not for diagnosis. 1
• Focus the workup on excluding other causes: thyroid dysfunction, depression, medication effects (especially SSRIs, antihypertensives), and other hormonal abnormalities. 4

Formulation and Dosing

Use transdermal testosterone formulations at doses that achieve physiologic to slightly supraphysiologic free testosterone levels. 1

• Transdermal preparations (patches, gels, creams) are preferred over oral or injectable forms. 2, 1
• Government-approved transdermal male formulations can be used cautiously with dosing adjusted appropriately for women (typically 1/10th of male doses). 1
• Target physiologic premenopausal testosterone concentrations during treatment. 1
• Avoid compounded testosterone products due to lack of efficacy and safety data, as well as significant variability in potency and quality between preparations. 1

Contraindications

Absolute contraindications:

• Women with breast cancer or history of breast cancer should not receive testosterone supplementation. 5
• Premenopausal women with chronic liver disease and hypogonadism should receive estrogen replacement (with progesterone if uterus present), not testosterone. 5

Monitoring and Safety

Monitor total testosterone levels to maintain concentrations in the physiologic premenopausal range and assess for signs of androgen excess. 1

• Check testosterone levels 3-6 weeks after initiation and dose adjustments. 1
• Monitor for androgenic side effects: acne, hirsutism, voice deepening, clitoral enlargement. 2, 3
• Oral testosterone (if used) may decrease HDL cholesterol, though transdermal and parenteral forms do not have this effect. 2
• Short-term safety data show no serious adverse events with physiologic testosterone use, but long-term effects on cardiovascular risk and breast cancer incidence are unknown. 3, 1

Informed Consent Requirements

Provide comprehensive informed consent before initiating therapy, including discussion of off-label use, benefits, and risks. 1

• Explain that testosterone is not FDA-approved for women. 3, 1
• Discuss the lack of long-term safety data, particularly regarding cardiovascular events and breast cancer. 3
• Review expected benefits: randomized controlled trials demonstrate moderate improvement in sexual function and libido compared to placebo. 2, 3, 1
• Document shared decision-making in the medical record. 1

Efficacy Evidence

Multiple randomized, double-blind, placebo-controlled trials demonstrate that testosterone improves libido significantly more than placebo in postmenopausal women with HSDD. 2, 3, 1

• The therapeutic benefit is moderate, not dramatic. 1
• Improvement includes increased sexual desire, arousal, and satisfying sexual events. 3
• Response should be assessed after 3-6 months of therapy at adequate dosing. 1

Special Populations

Premenopausal women with hypogonadism and chronic liver disease: Use transdermal estrogen replacement (with progesterone if uterus present) rather than testosterone. 5

Women desiring fertility preservation: Testosterone therapy is not appropriate, as it can suppress ovarian function. 5