Testosterone Therapy for Women

Important Safety Information — Testosterone Therapy for Women

Regulatory status

Not FDA-approved for any use. No testosterone product is FDA-approved for women in the United States; the FDA-approved testosterone gels are indicated only as replacement therapy in adult men with conditions that cause a deficiency or absence of testosterone, and their labels state they are not indicated for use in women. A licensed provider evaluates whether compounded testosterone cream may be considered for a postmenopausal woman diagnosed with hypoactive sexual desire disorder (HSDD) after a full clinical assessment, and whether other causes should be addressed first.

Off-label use. Testosterone is not FDA-approved for any use in women. Prescribing a compounded testosterone cream for postmenopausal hypoactive sexual desire disorder is an off-label, compounded use decided by your provider.

Do not use if

• You are pregnant or may become pregnant (FDA-approved testosterone labels list pregnancy as a contraindication)
• You are allergic to testosterone or any ingredient of the compounded cream
• You have not had a full assessment for hypoactive sexual desire disorder, or you are premenopausal (the consensus statement supports consideration only for postmenopausal women diagnosed with HSDD)

Before starting, tell your provider if

• A history of breast cancer or any other hormone-sensitive cancer (the consensus statement advises caution)
• Heart disease, high blood pressure, high cholesterol or triglycerides, diabetes or other cardiovascular or metabolic risk factors; women at high risk were excluded from the trials, and FDA-approved testosterone products for men warn of blood pressure increases, blood clots and lipid changes
• Liver problems, sleep apnea, swelling (edema) or a high red blood cell count, all of which appear in the warnings of FDA-approved testosterone products
• Acne, unwanted hair growth, hair thinning or voice changes, now or in the past
• Mood changes or a history of depression or anxiety
• All medicines and supplements you take, including estrogen and progestogen
• Breastfeeding
• Children or other people at home who could touch the area where the cream is applied

Serious side effects — get medical help right away

• Transfer to children and others (secondary exposure). FDA-approved testosterone gels carry a boxed warning that children who came into contact with unwashed or unclothed application sites developed signs of virilization, such as enlarged genitals or early pubic hair. Wash your hands after applying, let the area dry, cover it with clothing, and keep children and others from touching it. Report any such signs in a child to a health care professional right away.
• Signs of too much testosterone. New or worsening acne, increased facial or body hair, deepening of the voice, hair thinning on the scalp, enlargement of the clitoris or changes in periods can signal excess. Some of these changes may not reverse. Tell your provider promptly; blood levels are checked to screen for this.
• Blood pressure, blood clots and heart risks. FDA-approved testosterone products for men warn of blood pressure increases that can raise the risk of major cardiovascular events, of blood clots in the legs and lungs, and of a rise in red blood cells. Whether these apply to women at physiologic doses is not established; the consensus statement found insufficient data on heart attack and death. Get emergency help for chest pain, calf pain or swelling, sudden shortness of breath or stroke symptoms.
• Liver effects and mood changes. Liver problems and mood or behavior changes are listed in the labeling of FDA-approved testosterone products. Tell your provider about yellowing of the skin or eyes, dark urine, or marked changes in mood.

Common side effects

Common side effects reported in women in clinical trials at physiologic doses: a mild increase in acne and in facial or body hair in some women. Skin irritation where the cream is applied is listed for FDA-approved topical testosterone products. These are not all the possible side effects, and long-term safety in women has not been established.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Testosterone is contraindicated in women who are pregnant on the labels of FDA-approved testosterone products and should not be used if you may become pregnant. Tell your provider if you are breastfeeding.

Testosterone is a Schedule III controlled substance. Keep it where children and others cannot reach it, never share it, and follow federal and state rules for prescriptions, refills and disposal.

Avoid skin-to-skin contact with others at the application area until it is washed or covered. If someone else touches the area before it is washed, have them wash the skin with soap and water right away.

Prescription only. Testosterone Therapy is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.