Our Custom Rx Safety Information

Compound: Testosterone Transdermal Cream

Available Strengths: 0.5 mg/day, 1 mg/day, 2.5 mg/day, 3.75 mg/day

Dosage Form: Transdermal cream, applied once daily

Typical Use: Treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women, in combination with adequate estrogen therapy.

Usual Directions (example): Apply prescribed amount (typically 0.5-1 mg) once daily to clean, dry skin of inner thighs, inner forearms, or back of shoulders. Rotate application sites daily. Allow cream to dry fully before dressing.

Key Components & Risks

- Testosterone: Hormone naturally produced by women that declines with age. At physiologic doses, may improve sexual desire, arousal, and satisfaction in women with persistent low libido unresponsive to other treatments.

- Risks: androgenic side effects (acne, excess hair growth, scalp hair thinning, voice changes), potential cardiovascular effects, elevated red blood cell count, liver function changes, lipid profile changes.

Contraindications

- Known or suspected pregnancy or breastfeeding.

- Known or suspected breast cancer or other androgen-dependent cancers.

- Active or history of cardiovascular disease (use with caution and careful monitoring).

- Severe liver dysfunction or disease.

- Hypersensitivity to testosterone or cream components.

- Elevated hematocrit or polycythemia.

Warnings & Precautions

- Systemic absorption occurs; monitor for androgenic effects and laboratory abnormalities.

- Limited long-term safety data (studies typically <12 months); long-term cardiovascular and oncologic safety in women remains uncertain.

- Potential for virilizing effects including voice deepening and clitoral enlargement

- Monitor patients with history of hypertension, diabetes, hyperlipidemia, or cardiovascular risk factors.

- Use lowest effective dose for shortest duration consistent with treatment goals.

- Avoid skin-to-skin contact with others at application site for at least 2 hours to prevent inadvertent testosterone transfer.

Drug Interactions

- CYP3A4 inducers (rifampin, phenytoin, carbamazepine): may reduce testosterone effectiveness.

- Oral estrogens(particularly conjugated estrogens): may increase sex hormone-binding globulin (SHBG) and reduce free testosterone levels. Transdermal estrogen preferred when using testosterone.

- Corticosteroids: testosterone may enhance androgenic or metabolic effects.

- Anticoagulants: testosterone may enhance anticoagulant effect; monitor INR.

- Insulin or oral hypoglycemics: testosterone may alter glucose metabolism; monitor blood glucose.

Adverse Effects (Selected)

Local: application site reactions (redness, itching, irritation, rash).

Androgenic (dose-dependent, generally reversible):

- Acne or oily skin

- Increased facial or body hair growth

- Scalp hair thinning

- Mood changes or irritability

- Sleep disturbance

Serious or potentially irreversible:

- Voice deepening or hoarseness (rare at physiologic doses; requires immediate discontinuation)

- Clitoral enlargement (rare at physiologic doses; requires immediate discontinuation)

- Elevated hematocrit or polycythemia

- Adverse cardiovascular effects (data limited in women)

- Liver enzyme elevation

Monitoring (Per Prescriber)

Baseline (within 3 months prior to initiation):

- Total testosterone, SHBG, free testosterone

- Complete blood count (CBC)

- Comprehensive metabolic panel (CMP)

Initial Follow-Up (10-12 weeks after initiation or dose change):

- Symptom response (libido, sexual function, quality of life)

- Adverse effects assessment

- Adherence and application technique

- Labs: total testosterone, SHBG, free testosterone, CBC, CMP

Ongoing Monitoring:

- Every 6 months during the first year

- Annually thereafter if stable

- Labs: total testosterone, SHBG, free testosterone, CBC, CMP

Additional Monitoring (as indicated):

- Perform earlier or more frequent monitoring if symptoms of androgen excess, dose escalation, lab abnormalities, or patient near upper therapeutic range.

Safety Thresholds:

- Hematocrit >50%; reduce dose or hold therapy and evaluate

- Persistently supraphysiologic testosterone; reduce dose or discontinue

- Virilizing symptoms; hold therapy and reassess

Patient Counseling Points

- Apply testosterone cream once daily to clean, dry skin.

- Approved application sites: inner thighs, inner forearms (avoid elbow crease), or back of shoulders (posterior deltoid area).

- Rotate application sites daily to reduce skin irritation and ensure consistent absorption.

- Do not apply to: breasts, chest, genital area, or broken/irritated skin.

- Allow the cream to dry fully (at least 5 minutes) before dressing.

- Avoid skin-to-skin contact with others at the application site for at least 2 hours after application to prevent testosterone transfer to partners or children.

- Wash hands thoroughly after applying.

- Do not apply immediately before bathing, swimming, or heavy sweating.

- Report any of the following immediately: voice changes, unusual hair growth, severe acne, mood changes, chest pain, leg swelling, or other concerning symptoms.

- Inform all healthcare providers of testosterone use.

- Effects on sexual function typically take 3-6 months to become apparent; therapy requires patience and dose optimization.

Storage & Handling

- Store at controlled room temperature (20-25°C / 68-77°F).

- Protect from excessive heat and moisture.

- Keep container tightly closed.

- Keep away from children and pets.

- Dispose of unused medication properly per local guidelines.

References (Selected)

- Faubion SS, Parish SJ, Tan RB, Kingsberg SA. Clinical Practice Guidelines for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2019;16(10):1788-1800.

- Davis SR, et al. Testosterone for women: safety and efficacy. Climacteric. 2022.

- British Menopause Society and Women's Health Concern: Testosterone replacement in menopause. 2022.

- North American Menopause Society (NAMS) Position Statement on Hormone Therapy. 2022.

- AUA/SUFU/AUGS Guidelines on Genitourinary Syndrome of Menopause. 2025.

Disclaimer

This document is for clinical reference by licensed healthcare professionals. It does not replace prescriber judgment, patient-specific recommendations, or official labeling of individual drug products. Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved. Testosterone therapy for women is considered off-label use in the United States.