What is the recommended starting dose and administration route for testosterone therapy in an adult woman with hypoactive sexual desire disorder, menopausal symptoms, or documented hypogonadism?

Testosterone Dosing for Women

For postmenopausal women with hypoactive sexual desire disorder (HSDD), the recommended starting dose is 300 mcg/day of transdermal testosterone, which is the only evidence-based indication for testosterone therapy in women. 1, 2

Diagnostic Confirmation Required Before Treatment

Before initiating testosterone therapy, you must confirm:

• Documented HSDD diagnosis with distressing low sexual desire that causes personal distress 1, 3
• Postmenopausal status (either natural or surgical menopause), as this is the only population with robust efficacy data 1, 2, 3
• Exclusion of other causes of low desire, including relationship issues, depression, medications, or other medical conditions 3

The evidence for premenopausal women is extremely limited, with only one small pilot study (N=10) showing modest effects on arousal with PRN testosterone gel 4. Current guidelines do not support routine testosterone use in premenopausal women due to insufficient safety and efficacy data. 3

Recommended Formulation and Dosing

Transdermal Testosterone (Preferred Route)

Start with 300 mcg/day transdermal testosterone patch or gel, which has been validated in multiple Phase III randomized controlled trials 2, 3. This dose:

• Produces physiologic testosterone levels in the mid-normal female range 2
• Demonstrates statistically significant and clinically meaningful improvements in sexual desire and satisfying sexual events 1, 2
• Has a favorable short-term safety profile with minimal androgenic side effects 2, 3

Transdermal administration is strongly preferred over oral or injectable routes because:

• It avoids hepatic first-pass metabolism and provides more stable serum levels 5
• Oral testosterone formulations cause dose-dependent hepatotoxicity and are not recommended for women 5
• Injectable testosterone produces supraphysiologic peaks that increase adverse effect risk 5, 6

Practical Application Details

For testosterone gel (off-label use of male formulations, as no FDA-approved female product exists in the US):

• Apply a small amount (approximately 5-10 mg of male gel formulation) to achieve target dose of 300 mcg absorbed 3
• Apply to non-genital skin (inner thigh or lower abdomen) once daily 3
• Allow gel to dry completely before dressing to prevent transfer 6
• Wash hands thoroughly after application 6

For testosterone patch (if available):

• Apply 300 mcg patch to clean, dry skin on lower abdomen or upper outer thigh 2
• Rotate application sites to minimize skin irritation 2
• Replace patch twice weekly 2

Monitoring Protocol

Initial Assessment (Before Starting)

• Baseline total testosterone (morning sample, 8-10 AM) to document low-normal or low levels 3
• Baseline lipid panel, liver function tests, and complete blood count 3
• Breast and endometrial cancer screening up to date per age-appropriate guidelines 2, 3

Follow-Up Monitoring

At 3-6 months after initiation:

• Measure total testosterone level (target mid-normal female range: 30-50 ng/dL) 3
• Assess clinical response using validated sexual function questionnaires 1, 2
• Evaluate for androgenic side effects (acne, hirsutism, voice changes) 2, 3
• Check hematocrit/hemoglobin (testosterone can increase red blood cell production) 3

If no meaningful clinical benefit after 6 months, discontinue therapy, as women will only continue if they experience meaningful improvement 7, 3

If clinical benefit is achieved, continue with annual monitoring:

• Total testosterone level annually 3
• Lipid panel, liver function tests, and complete blood count annually 3
• Breast and endometrial cancer screening per standard guidelines 2, 3
• Clinical assessment of sexual function and side effects 3

Expected Treatment Outcomes

Realistic expectations to discuss with patients:

• Modest but meaningful improvements in sexual desire and frequency of satisfying sexual events (approximately 1-2 additional satisfying events per month compared to placebo) 1, 2
• Effects typically emerge within 3-4 months of starting therapy 7, 2
• No proven benefit for energy, cognition, bone health, or general well-being in women 3
• Standardized mean difference of approximately 0.35 for sexual function improvements, similar to the effect size seen in men with hypogonadism 8

Common Side Effects and Safety Concerns

Short-Term Side Effects (Well-Documented)

• Increased hair growth (most common, typically mild) 2, 3
• Acne (usually mild and manageable) 2, 3
• Application site reactions with patches (can switch to gel if problematic) 2

Long-Term Safety Considerations

Cardiovascular safety: Interim data from long-term trials show low rates of cardiovascular events, though definitive long-term data are still being collected 2, 3

Breast cancer risk: Current evidence suggests androgens may actually suppress proliferative effects of estrogen and progesterone, but long-term data are incomplete 7, 2, 3

Endometrial safety: No evidence of increased endometrial cancer risk in available studies 2

The lack of long-term safety data (>2 years) is precisely why no FDA-approved testosterone formulation exists for women in the United States. 3

Absolute Contraindications

Do not prescribe testosterone if:

• Active or history of breast cancer (theoretical risk of androgen-sensitive tumor stimulation) 2, 3
• Active or history of endometrial cancer 3
• Pregnancy or breastfeeding (Category X) 3
• Desire for fertility preservation (though this is rarely relevant in postmenopausal women) 8
• Severe liver disease (impaired testosterone metabolism) 3

Special Clinical Scenarios

Women on Concurrent Estrogen Therapy

Testosterone can be safely combined with estrogen/progestin hormone therapy in postmenopausal women 2, 3. Most Phase III trials included women on concurrent estrogen therapy, demonstrating efficacy and safety in this population 2.

Surgically Menopausal Women (Post-Oophorectomy)

Surgically menopausal women often have more severe testosterone deficiency and may experience greater benefit from testosterone therapy 7, 2. The dosing and monitoring approach remains the same as for naturally menopausal women 2.

Premenopausal Women

Evidence is extremely limited for premenopausal women with HSDD. One small pilot study (N=10) used PRN testosterone gel (applied 4-8 hours before planned intercourse) and showed modest improvements in arousal, but this approach requires further validation 4. Current guidelines do not support routine testosterone use in premenopausal women due to insufficient data. 3

Critical Pitfalls to Avoid

Do not use male testosterone formulations at male doses – this will produce supraphysiologic levels and significant androgenic side effects 3

Do not prescribe testosterone for non-HSDD indications (energy, cognition, bone health) in women, as there is no evidence of benefit 3

Do not continue therapy beyond 6 months if no clinical benefit – women report meaningful benefit or they discontinue, so lack of response indicates therapy should be stopped 7, 3

Do not skip baseline and follow-up testosterone monitoring – this is essential to ensure physiologic dosing and avoid supraphysiologic levels 3

Do not prescribe oral testosterone formulations – these cause hepatotoxicity and are not appropriate for women 5