Otc testosterone for women

The Truth About Over-the-Counter Testosterone Treatment

Talking about your experience with low testosterone can be difficult, but it’s critical to ensure you get the right care. If you’re ready to get back to living life at your optimal level of health, reach out to a practitioner who understands your needs and will help you forge a path toward recovery.

BodyLogicMD is a network of highly-qualified hormone health practitioners who specialize in helping men find the right treatment for the symptoms of low testosterone. BodyLogic-affiliated practitioners work with men from all walks of life and all stages of the aging process to feel their best and achieve optimal wellness. Contact a local practitioner to start your journey toward improved emotional, mental, and physical health. Or, take the BodyLogicMD Hormone Balance Quiz to get a better idea of how testosterone and other hormones might be impacting your everyday life.

Disclaimer: These statements have not been evaluated by the Food and Drug Administration. All content on this website is for informational purposes only. The content is not intended to diagnose, treat, cure or prevent diseases.

Charlotte is a patient care coordinator specializing in bioidentical hormone replacement therapy. She is committed to helping patients who struggle with the symptoms of hormonal change and imbalance explore their treatment options and develop effective strategies to optimize wellness.

Testosterone Injection

Generic Name: testosterone injection (tes TOS ter one)
Brand Names: Aveed, Delatestryl, Depo-Testosterone, Testosterone Cypionate, Testosterone Enanthate, Testosterone undecanoate, Xyosted

Medically reviewed by Kaci Durbin, MD Last updated on Jan 17, 2019.

  • Overview
  • Side Effects
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What is testosterone?

Testosterone is a naturally occurring sex hormone that is produced in a man’s testicles. Small amounts of testosterone are also produced in a woman’s ovaries and adrenal system.

Testosterone injection is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or growth. It is only recommended for males with a known medical condition, such as a genetic disorder, problem with certain brain structures (called the hypothalamus and pituitary) or previous chemotherapy.

Testosterone injection is also used in women to treat certain types of breast cancer that have spread to other parts of the body.

Testosterone should not be used to enhance athletic performance or to treat normal male aging.

Important information

Do not use this medicine if you are pregnant or may become pregnant.

You should not receive testosterone if you have prostate cancer, male breast cancer, a serious heart condition, or severe liver or kidney disease.

Misuse of testosterone can cause dangerous or irreversible effects. Testosterone injections should be given only by a healthcare professional. Testosterone can lead to serious problems with the heart, brain, liver, endocrine, and mental health systems. Stopping testosterone may also lead to unpleasant withdrawal symptoms.

Testosterone injections have also been linked to a condition called pulmonary oil microembolism (POME), or a blood clot in the lung that can be fatal. Seek medical help immediately for symptoms including chest pain, dizziness, trouble breathing, urge to cough, throat tightening and fainting.

Before taking this medicine

You should not receive testosterone if you are allergic to it, or if you have:

  • prostate cancer;

  • male breast cancer;

  • a serious heart condition;

  • severe liver disease;

  • severe kidney disease; or

  • if you are pregnant or may become pregnant.

To make sure testosterone is safe for you, tell your doctor if you have:

  • heart disease or coronary artery disease;

  • a history of heart attack, stroke, or blood clot;

  • diabetes;

  • enlarged prostate;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • breast cancer (in men, or in women who have hypercalcemia);

  • liver or kidney disease;

  • high calcium levels;

  • if you are bedridden or otherwise debilitated; or

  • if you take a blood thinner (warfarin, Coumadin, Jantoven).

This medicine can harm an unborn baby or cause birth defects. Do not use testosterone if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are receiving this medicine.

It is not known whether testosterone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is testosterone injection given?

Testosterone is injected into a muscle. The injection is usually given every 2 to 4 weeks.

Testosterone injections should be given only by a healthcare professional. Misuse can lead to serious side effects or death.

The length of treatment will depend on the condition being treated.

Testosterone will not enhance athletic performance and should not be used for that purpose.

While receiving this medicine, you will need frequent blood tests.

Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

What happens if I miss a dose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. If overdose does occur, it can lead to death. Seek medical attention immediately.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving testosterone injection?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Testosterone side effects

Get emergency medical help if you have any signs of an allergic reaction to testosterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have any signs of a blood clot in the lung after using testosterone. These symptoms include chest pain, dizziness, trouble breathing, urge to cough, throat tightening and fainting.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Call your doctor at once if you have:

  • chest pain or pressure, pain spreading to your jaw or shoulder;
  • swelling in your ankles or feet, rapid weight gain;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • nausea or vomiting;
  • changes in skin color;
  • increased or ongoing erection of the penis;
  • impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;
  • painful or difficult urination;
  • shortness of breath (even with mild exertion);
  • stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:

  • acne;

  • changes in menstrual periods;

  • male-pattern hair growth (such as on the chin or chest);

  • hoarse or deepened voice; or

  • enlarged clitoris.

Common testosterone side effects (in men or women) may include:

  • breast swelling;

  • headache, anxiety;

  • increased facial or body hair growth, male-pattern baldness;

  • increased or decreased interest in sex;

  • numbness or tingly feeling; or

  • pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect testosterone?

Certain drugs may interact with testosterone, including;

  • Blood thinners (including warfarin, Coumadin, Jantoven)
  • Anti-inflammatory drugs, such as oxyphenbutazone

Other prescription and over-the-counter medicines, vitamins, and herbal products may also react with testosterone. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 2.05.

Related questions

  • Is Xyosted a controlled substance?
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More about testosterone

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  • Testosterone Buccal Tablets
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  • Testosterone Enanthate (Intramuscular)
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Other brands: AndroGel, Depo-Testosterone, Androderm, Xyosted, … +10 more

Professional resources

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Related treatment guides

  • Hypogonadism, Male
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Is testosterone therapy safe? Take a breath before you take the plunge

Understand the potential risks and consider alternatives before boosting your hormones indefinitely.

Updated: December 14, 2018Published: February, 2014

Millions of American men use a prescription testosterone injection or gel as forms of testosterone replacement therapy (often referred to as TRT therapy) to restore normal levels of the manly hormone. The ongoing pharmaceutical marketing blitz promises that low T treatment can make men feel more alert, energetic, mentally sharp, and sexually functional. However, legitimate safety concerns linger. For example, some older men on testosterone replacement therapy could face higher cardiac risks.

“Because of the marketing, men have been flooded with information about the potential benefit of fixing low testosterone, but not with the potential costs,” says Dr. Carl Pallais, an endocrinologist and assistant professor of medicine at Harvard Medical School. “Men should be much more mindful of the possible long-term complications.”

Signs of low testosterone

MIND
• Depression
• Reduced self-confidence
• Difficulty concentrating
• Disturbed sleep

BODY
• Declining muscle and bone mass
• Increased body fat
• Fatigue
• Swollen or tender breasts
• Flushing or hot flashes

SEXUAL FUNCTION
• Lower sex drive
• Fewer spontaneous erections
• Difficulty sustaining erections

The low-T boom

A loophole in FDA regulations allows pharmaceutical marketers to urge men to talk to their doctors if they have certain “possible signs” that mean they could need low T treatment. “Virtually everybody asks about this now because the direct-to-consumer marketing is so aggressive,” says Dr. Michael O’Leary, a urologist at Harvard-affiliated Brigham and Women’s Hospital. “Tons of men who would never have asked me about it before started to do so when they saw ads that say ‘Do you feel tired?'”

Just being tired isn’t enough to seek testosterone replacement therapy. “General fatigue and malaise is pretty far down my list,” Dr. O’Leary says. “But if they have significant symptoms, they’ll need to have a lab test. In most men the testosterone level is normal.”
If a man’s testosterone looks below the normal range, there is a good chance he could end up on TRT hormone supplements — often indefinitely. “There is a bit of a testosterone trap,” Dr. Pallais says. “Men get started on testosterone replacement and they feel better, but then it’s hard to come off of it. On treatment, the body stops making testosterone. Men can often feel a big difference when they stop therapy because their body’s testosterone production has not yet recovered.”

This wouldn’t matter so much if we were sure that long-term hormone therapy is safe, but some experts worry that low-T therapy is exposing men to small risks that could add up to harm over time.

What are the risks of testosterone therapy?

A relatively small number of men experience immediate side effects of testosterone treatment, such as acne, disturbed breathing while sleeping, breast swelling or tenderness, or swelling in the ankles. Doctors also watch out for high red blood cell counts, which could increase the risk of clotting.

Men on long-term using forms of testosterone therapy long term appear to have a higher risk of cardiovascular problems, like heart attacks, strokes, and deaths from heart disease. For example, in 2010, researchers halted the Testosterone in Older Men study when early results showed that men on testosterone replacement therapy had noticeably more heart problems. “In older men, theoretical cardiac side effects become a little more immediate,” Dr. Pallais says.

Some physicians also have a lingering concern that testosterone therapy could stimulate the growth of prostate cancer cells. As with the hypothetical cardiac risks, the evidence is mixed. But because prostate cancer is so common, doctors tend to be leery of prescribing testosterone to men who may be at risk.

For male patients with low blood testosterone levels, the benefits of hormone replacement therapy for men usually outweigh potential risks. However, for most other men it’s a shared decision with your doctor. It offers men who feel lousy a chance to feel better, but that quick fix could distract attention from unknown long-term hazards. “I can’t tell you for certain that this raises your personal risk of heart problems and prostate cancer, or that it doesn’t,” Dr. Pallais says.

So, keep risks in mind when considering testosterone therapy or other therapies . “I frequently discourage it, particularly if the man has borderline levels,” Dr. Pallais says.

Easy energy boosters

These steps can help you feel more energetic today without drugs or dietary supplements:

  • Pace yourself: Spread out activities throughout the day.

  • Take a walk: It gives you a lift when you feel pooped out.

  • Snack smart: Have a snack with fiber and some protein between meals.

Take a cautious approach

A large, definitive trial for hormone treatment of men is still to come. Until then, here is how to take a cautious approach to testosterone therapy.

Take stock of your health first

  • Have you considered other reasons why you may be experiencing fatigue, low sex drive, and other symptoms attributable to low testosterone? For example, do you eat a balanced, nutritious diet? Do you exercise regularly? Do you sleep well? Address these factors before turning to hormone replacement therapy for men.

  • If your sex life is not what it used to be, have you ruled out relationship or psychological issues that could be contributing?

  • If erectile dysfunction has caused you to suspect “low T” as the culprit, consider that cardiovascular disease can also cause erectile dysfunction.

Get an accurate assessment

  • Inaccurate or misinterpreted test results can either falsely diagnose or miss a case of testosterone deficiency. Your testosterone level should be measured between 7 am and 10 am, when it’s at its peak. Confirm a low reading with a second test on a different day. It may require multiple measurements and careful interpretation to establish bioavailable testosterone, or the amount of the hormone that is able to have effects on the body. Consider getting a second opinion from an endocrinologist.

  • After starting therapy, follow-up with your physician periodically to have testosterone checks and other lab tests to make sure the therapy is not causing any problems with your prostate or blood chemistry.

Be mindful of unknown risks of testoerone replacement therapy

  • Approach testosterone therapy with caution if you are at high risk for prostate cancer; have severe urinary symptoms from prostate enlargement; or have diagnosed heart disease, a previous heart attack, or multiple risk factors for heart problems.

  • Ask your doctor to explain the various side effects for the different formulations of testosterone. The different treatments include testosterone injections, gels and patches. Know what to look for if something goes wrong.

Have realistic expectations

Testosterone therapy is not a fountain of youth. There is no proof that it will restore you to the level of physical fitness or sexual function of your youth, make you live longer, prevent heart disease or prostate cancer, or improve your memory or mental sharpness. Do not seek TRT therapy with these expectations in mind.

If erectile function has been a problem, testosterone therapy might not fix it. In fact, it might increase your sex drive but not allow you to act on it. You may also need medication or other therapy for difficulty getting or maintaining erections.

Top Image: iStock

Disclaimer:
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.

US Pharm. 2014;39(8):42-46.

ABSTRACT: Approximately 43% of women in the United States between the ages of 18 and 59 years experience sexual dysfunction. Hypoactive sexual desire disorder (HSDD) is characterized by the absence of sexual fantasies and desire for sexual activity. Male sexual dysfunction has been extensively researched, but there is less evidence addressing the treatment of HSDD in women, particularly with regard to the use of androgen therapy. There are no FDA-approved testosterone treatments for women, despite the fact that 4 million prescriptions have been written off-label for HSDD. This highlights the need for more research on safety, efficacy, side effects, and transference issues.

In 2011, the FDA Reproductive and Urologic Drug Products Advisory Committee stated that hypoactive sexual desire disorder (HSDD) is a significant medical condition for women. HSDD, which is considered to be a form of sexual dysfunction, is characterized by the absence of sexual fantasies and desire for sexual activity, as judged by a clinician. In 1999, it was reported that the proportion of U.S. women aged 18 to 59 years with sexual dysfunction was 43%.1 HSDD in women cannot be diagnosed by assessing the level of circulating sex hormones, such as testosterone; some women with low testosterone levels do not experience desire problems, and most women with HSDD have normal testosterone levels. Male sexual dysfunction has been extensively researched, but there is less evidence addressing the treatment of HSDD in women, particularly with regard to the use of androgen therapy. The complexity of factors involved in HSDD and the lack of awareness that low desire associated with distress is a medical condition have slowed the development of drugs specifically designed for women.

Testosterone is considered to be the main hormone underlying sexual desire in both men and women. In healthy women, free testosterone levels have been linked to sexual desire and antiandrogen therapy has been linked to loss of sexual desire.2 Combinations of oral esterified estrogens and methyltestosterone, including Estratest and Estratest HS (half-strength), have been marketed in the U.S. since 1964. These products are for the treatment of moderate-to-severe vasomotor symptoms associated with menopause in female patients whose symptoms have not been relieved by estrogens alone. There are no testosterone pills, patches, or gels currently approved by the FDA for treating sexual dysfunction in women.

Transdermal testosterone gels were introduced in the U.S. in 2000. Two gels are approved in the U.S. for men: AndroGel and Testim (1%). These topically applied products are a favorable and popular mode of testosterone replacement therapy. The usual starting dose for testosterone gels in men is 50 to 60 mg per day. Survey data on the prescribing of testosterone by U.S. physicians in 2009 found that approximately 4 million prescriptions for estrogen/androgen oral medications, compounded testosterone, or brand testosterone approved for use in men were written off-label for women.3 Since the commercially available dosages are too strong for women, female patients typically are treated with testosterone compounded at a dosage of 0.5 to 2 mg per day.

For postmenopausal women with secondary HSDD, the administration of androgens, testosterone patches, or a combination of estrogen and methyltestosterone was reported to be moderately beneficial.4 Manufacturers have tried to gain FDA approval of two testosterone products for HSDD; both were denied, however. The first product, Intrinsa—a 300-mcg/24-hour testosterone patch developed by Procter & Gamble—failed to receive approval following phase III trials because of long-term safety issues.5 However, the product was licensed by the European Medicines Agency for the treatment of HSDD in women undergoing bilateral oophorectomy and hysterectomy (i.e., surgically induced menopause) who receive concomitant estrogen therapy. The second product, LibiGel, was a 1% testosterone hydroalcoholic gel applied in pea-sized amounts to a small area of skin on the upper arm. Administered once daily, LibiGel increased serum free testosterone levels in postmenopausal women to the testosterone range of younger, premenopausal women.6 The FDA ended BioSante Pharmaceuticals’ trials of LibiGel based on an initial analysis of trial data showing nonsignificant differences between the treatment and placebo arms for the secondary endpoints.7

Testosterone Production and Metabolism in Women

Testosterone is important for women since it is a major precursor of estradiol production. In premenopausal women, circulating testosterone levels are approximately 10-fold greater than estradiol levels.2 The normal range for testosterone in women is 15 to 70 ng/dL, and by the time women reach their 40s, their blood testosterone levels are approximately one-half less than in their 20s.2

Approximately one-third of circulating testosterone comes directly from the ovaries; the remaining two-thirds derives from peripheral conversion of precursors from the ovaries and the adrenal gland. Because the ovaries account for roughly 50% of circulating testosterone, bilateral oophorectomy significantly reduces testosterone levels.8,9 In contrast, spontaneous menopause is not associated with a significant change in circulating testosterone levels. The postmenopausal ovary appears to produce testosterone throughout life, although not all studies are in agreement.8,9

A number of factors can lead to reduced testosterone levels in women. See TABLE 1 for a summary.10

Advantages and Disadvantages of Testosterone Use in Women

Several randomized, controlled trials of exogenous testosterone therapy in postmenopausal women suggested improvements in sexual desire, sexual responsiveness, and frequency of sexual activity.11-14 With the exception of a particular testosterone-alone arm in one study that included no data on adverse events, these trials combined testosterone with either estrogen therapy or, for women with an intact uterus, estrogen-progestin therapy.11-15 However, despite findings of short-term efficacy for testosterone therapy in women, reviews of safety in long-term studies are lacking.

Possible beneficial effects of testosterone therapy, such as reduced fracture risk and improved cognitive function, require further research. It is difficult to know which route of administration is more advantageous; however, transdermal application has several advantages over other forms of administration. When testosterone is taken orally, there is extensive first-pass metabolism in the liver that would be prevented with topical application. IM injections are invasive, but topical gels are painless and easy to apply. There are peaks and troughs associated with injections, whereas the topical method remains constant. With patches, there is a limited amount of exposure to the medication, but this modality is often associated with application-site reactions, and the patch is visible on the skin.16

Limitations of testosterone treatment in women include the variety of side effects, contraindications, and concerns about long-term use. These factors have delayed the development of an effective, safe treatment option for HSDD and other female disorders, including primary ovarian insufficiency (POI). POI is a disorder accompanied by infertility, depression, an increased risk of osteoporosis, and cardiovascular disease. Compared with women with normal ovarian function, those with POI have reduced ovarian production of estradiol and progesterone and decreased circulating levels of androgens.17 Testosterone production is insufficient in this disorder, so testosterone therapy would be a sensible method for restoring circulating testosterone levels to a normal range.

Although studies have shown benefits from testosterone use, there are contraindications to its use in women. Women who could become pregnant should avoid testosterone therapy, because its use during pregnancy introduces the risk of the development of male traits in a female fetus. Testosterone therapy should also be avoided in women who have or have had breast or uterine cancer, have high cholesterol or heart disease, or have liver disease.2

A study using combined estrogen and testosterone preparations for treatment showed uncommon side effects of alopecia, acne, and hirsutism, although these side effects are dependent on dosage and duration.15 Low incidence rates of deep voice, oily skin, acne, and male-pattern hair loss were found in a few controlled studies. Virilization can occur with higher-than-normal dosing of testosterone, but it is uncommon and reversible.18 Women using the lowest effective dosage of testosterone have not been shown to experience side effects or adverse events. Increased dosages inevitably result in the aforementioned adverse effects, as well as increased hair growth.11-15

Testosterone Transference

Transference is the direct or indirect displacement of testosterone from the skin of the patient to someone or something else. Transference issues have been extensively studied in men, which led to the FDA issuing a black box warning for testosterone products regarding the threat of virilization from topical dosage forms.19,20 In contrast, transference has not undergone in-depth study in women. Transference to partners, family members, friends, children, or animals could be an issue. There are documented cases of transference in men, but there are no studies documenting transference from women undergoing testosterone treatment.

In order to prevent transference, it is best to avoid all contact until the drug is either completely absorbed or washed clean. The time necessary for absorption varies per product; however, each product comes with a medication guide that should be read fully before use. If skin-to-skin contact with another person or an animal cannot be avoided, covering the application site with clothing decreases risk of transfer. If accidental contact occurs, immediately wash the affected areas with soap and water. It is important to note that skin-to-skin contact is not the sole method of transference. Caution should be taken with regard to shared inanimate objects, as well as residue on furniture, sheets, and clothing. Key prevention methods include washing the hands immediately after application, applying the drug only to indicated areas, covering the area with clothing once dry, cleansing the area before sleeping on bedding, and washing all fabrics that have come in contact with the application site.21

It is important for pharmacists to instruct patients on safe storage of all their medications and educate them about the signs and symptoms of transference. Enlarged genitalia, early development of pubic hair, increased erections or libido, and aggressive behavior are signs and symptoms of early puberty and accidental exposure. Women will develop changes in body hair or a noticeable increase in acne, which are also signs and symptoms of exposure. In such cases, the testosterone product should be discontinued and the primary healthcare provider should be contacted.21

Conclusion

Since the emergence of testosterone products in the 1990s and transdermal gels in 2000, there have been several approved products on the market for testosterone replacement therapy in men, but there are currently no FDA-approved products for women. Although androgen insufficiency is a clinical symptom of multiple disease states in men, androgen is considered to be the primary hormone underlying sexual desire in both men and women. Testosterone, along with estrogen and progesterone, is elemental in the development of increased libido in females.

Decreased libido is a common complaint among women and is the leading cause of several sexual-dysfunction disorders, such as HSDD. Coupled with the dearth of approved treatments and the lack of knowledge and clinical research on the disease states themselves, a wide gap has been left in the care of female patients. Despite testosterone’s apparent benefits, it is contraindicated in certain female populations. In addition, unconfirmed doses lead to many unwanted potential adverse effects, and transference issues still pose an issue. Measures can be taken to prevent transference, as with men, and it is crucial that women receiving testosterone therapy receive appropriate and necessary counseling.

Androgen therapy in women is an important topic and has been recognized as such by several groups in the past few years.22 Even in the absence of FDA approval, it is apparent that testosterone therapy has some use in certain female populations; however, extensive clinical research on all aspects of the subject is needed in order to formulate guidelines on appropriate indications, dosages, and safety. It is recommend that the medical community delve deeper into not only androgen therapy, but also the conditions requiring it. Additional information on normal laboratory values and assessments of the safety and efficacy of testosterone therapy in all populations of women will greatly improve our knowledge base.

1. Guay A, Davis SR. Testosterone insufficiency in women: fact or fiction? World J Urol. 2002;20:106-110.
2. Davis SR, Davison SL. Current perspectives on testosterone therapy for women. Menopausal Med. 2012;20:S1-S4.
3. Snabes MC, Milling WM, Simes SM. Without FDA-approved testosterone to treat women with hypoactive sexual desire disorder providers rely on off-label prescribing. J Sex Med. 2011;8:185. Abstract 18A.
4. Bloch M, Meiboom H, Zaig I, et al. The use of dehydroepiandrosterone in the treatment of hypoactive sexual desire disorder: a report of gender differences. Eur Neuropsychopharmacol. 2013;23(8):910-918.
5. FDA. FDA Intrinsa Advisory Committee Background Document Overview. December 4, 2004. www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4082b1_02_a-fda-intrinsa-overview.htm. Accessed July 17, 2014.
6. White WB, Grady D, Giudice LC, et al. A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder. Am Heart J. 2012;163:27-32.
7. Kingsberg SA. The Hypoactive Sexual Desire Disorder Registry to characterize the natural history and outcomes of women with hypoactive sexual desire disorder. Menopause. 2012;19:379-381.
8. Seidman SN, Rabkin JG. Testosterone replacement therapy for hypogonadal men with SSRI-refractory depression. J Affect Disord. 1998;48:157-161.
9. Judd HL, Lucas WE, Yen SS. Effect of oophorectomy on circulating testosterone and androstenedione levels in patients with endometrial cancer. Am J Obstet Gynecol. 1974;118:793-798.
10. North American Menopause Society. The role of testosterone therapy in postmenopausal women: position statement of The North American Menopause Society. Menopause. 2005;12:496-511.
11. Laughlin GA, Barrett-Connor E, Kritz-Silverstein D, von Mühlen D. Hysterectomy, oophorectomy, and endogenous sex hormone levels in older women: the Rancho Bernardo Study. J Clin Endocrinol Metab. 2000:85:645-651.
12. Burger HG, Hailes J, Nelson J, Menelaus M. Effect of combined implants of estradiol and testosterone on libido in postmenopausal women. Br Med J (Clin Res Ed). 1987;294:936-937.
13. Davis SR, McCloud P, Strauss BJ, Burger H. Testosterone enhances estradiol’s effects on postmenopausal bone density and sexuality. Maturitas. 1995;21:227-236.
14. Sarrel P, Dobay B, Wiita B. Estrogen and estrogen-androgen replacement in postmenopausal women dissatisfied with estrogen-only therapy: sexual behavior and neuroendocrine responses. J Reprod Med. 1998;43:847-856.
15. Lobo RA, Rosen RC, Yang HM, et al. Comparative effects of oral esterified estrogens with and without methyltestosterone on endocrine profiles and dimensions of sexual function in postmenopausal women with hypoactive sexual desire. Fertil Steril. 2003;79:1341-1352.
16. Sherwin BB, Gelfand MM, Brender W. Androgen enhances sexual motivation in females: a prospective, crossover study of sex steroid administration in surgical menopause. Psychosom Med. 1985;47:339-351.
17. de Ronde W. Hyperandrogenism after transfer of topical testosterone gel: case report and review of published and unpublished studies. Hum Reprod. 2009;24:425-428.
18. Guerrieri GM, Martinez P, Klug SP, et al. Effects of physiologic testosterone therapy on quality of life, self-esteem, and mood in women with primary ovarian insufficiency. Menopause. January 27, 2014 .
19. FDA. Letter to Solvay Pharmaceuticals, Inc. regarding safety labeling changes and Risk Evaluation and Mitigation Strategies for AndroGel. May 7, 2009.
20. FDA. Letter to Auxilium Pharmaceuticals, Inc. regarding safety labeling changes and Risk Evaluation and Mitigation Strategies for Testim. May 7, 2009.
21. FDA. Medication Guide: Testosterone Gel CIII. www.fda.gov/downloads/Drugs/DrugSafety/UCM403065.pdf. Accessed July 17, 2014.
22. Wierman ME, Basson R, Davis SR, et al. Androgen therapy in women: an Endocrine Society Clinical Practice guideline. J Clin Endocrinol Metab. 2006;91:3697-3710.

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Risks of Testosterone Therapy

Testosterone replacement therapy side effects most often include rash, itching, or irritation at the site where the testosterone is applied.

However, there is also evidence of a possible increased risk of heart attack or stroke associated with testosterone use. Experts emphasize that the benefits and risks of long-term testosterone therapy are unknown, because large clinical trials haven’t yet been done.

There are a few health conditions that experts believe testosterone therapy can worsen:

  • Benign prostatic hypertrophy (BPH): The prostate grows naturally under the stimulation of testosterone. For many men, their prostates grow larger as they age, squeezing the tube carrying urine (urethra). The result is difficulty urinating. This condition, benign prostatic hypertrophy, can be made worse by testosterone therapy.
  • Prostate cancer: Testosterone can stimulate prostate cancer to grow. Most experts recommend screening for prostate cancer before starting testosterone replacement. Men with prostate cancer or elevated prostate specific antigen (PSA) should probably avoid testosterone treatment.
  • Sleep apnea: This condition can be worsened by testosterone replacement. It may be difficult for a man to detect this himself, but his sleeping partner can often tell. A sleep study (polysomnography) may be needed to make the diagnosis.
  • Blood clots: The FDA requires that testosterone replacement products carry a warning about the risk of blood clots in veins. This could increase the risk of deep vein thrombosis and pulmonary embolism , a potentially life threatening clot that occurs in the lungs. Products already carried a warning about the risk of blood clots due to polycythemia, an abnormal rise in the number of red blood cells that sometimes occurs with testosterone treatment. Now the warning is more general to include men who don’t have polycythemia.
  • Congestive heart failure: Men with severe congestive heart failure should usually not take testosterone replacement, as it can worsen the condition.

It will be years before large clinical trials bring any answers on the long-term benefits and risks of testosterone therapy. As with any medicine, the decision on whether the possible benefits outweigh any risks is up to you and your doctor.

Depending on age and individual makeup, typical testosterone levels in adult men range widely, from 280–1,100 ng/dl, according to researchers at the University of Rochester. Most adult men average about 679 ng/dl, although some researchers suggest that 400–600 is optimal in healthy individuals. Testosterone decreases naturally with age, but slowly, at a rate of about 1 percent a year after age 30. Low testosterone can also be caused by tumors in the pituitary gland or testes, especially in younger men, as well as diseases such as type 2 diabetes. It also has been strongly linked to obesity.

So what are the signs of low testosterone? They include low sex drive, fatigue, loss of muscle mass, decreased bone mass, increased body fat and mood changes, including irritability or lack of focus.

Multiple studies have found that testosterone effectively boosts libido and sexual function for older men with hypogonadism. TRT also has been linked to modest increases in bone density, muscle tone and grip strength.

But few of the other claims about TRT, which typically costs about $400 a month and is sometimes not covered by insurance, pan out. For instance, several recent studies corroborating TRT’s positive effects on libido in older men with hypogonadism also found that TRT had no meaningful effect on fatigue, depression, memory, emotional state, enhanced cognition, mood or energy — the two most common reasons men give for seeking out the drug, other than libido — compared to control groups. In addition to the increased risk of heart disease and stroke, scientists currently are debating the role of TRT in the development of prostate cancer.

Comparatively, hypogonadism affects about 3 percent to 5 percent of men under age 45. For them, side effects may be much more dangerous, including permanent infertility, said Halis Kaan Akturk, a professor of medicine at the University of Colorado and formerly a doctor at the Mayo Clinic. Akturk said he sees at least one patient per day seeking testosterone, many of them former student athletes now in their 20s and 30s, who began taking testosterone early and are now dependent.

“If we give someone testosterone, we are making their testicles lazy,” Akturk said. “In these patients, who have been using testosterone for five to six years, their testicles get atrophied and sometimes permanently damaged. It’s a hard thing to wean people off of.”

What’s more, abnormally low testosterone in younger men can indicate a different, often serious problem, which artificially upping testosterone levels can make the both harder to detect and treat, Akturk said. Treatment for prostate cancer, for instance, a common cause of abnormally low testosterone in young men, typically involves decreasing the amount of testosterone in the bloodstream. Excess testosterone can “wake sleeping tumors,” Akturk said.

Akturk was part of a team of Mayo Clinic doctors who treated a 56-year-old man who went blind in both eyes soon after starting testosterone therapy prescribed by his doctor. Akturk and the other doctors traced the blindness — as well as the man’s original symptoms, for which he sought testosterone therapy and which still had not abated — to a tumor in his pituitary gland. The testosterone, they found, had stimulated the tumor further.

After stopping testosterone therapy and prescribing medication to decrease the amount of testosterone in the bloodstream, the man’s eyesight mercifully returned. “It needs to be worked out why this person has low testosterone, rather than just giving them testosterone,” Akturk said.

That does not appear to be happening in practice, however. Only half of the men at a medical center interested in TRT had a clinical diagnosis of hypogonadism, according to a 2017 study by researchers at Emory University School of Medicine, and about 10 percent knew about side effects.

Testosterone injection

What is this medicine?

TESTOSTERONE (tes TOS ter one) is the main male hormone. It supports normal male development such as muscle growth, facial hair, and deep voice. It is used in males to treat low testosterone levels.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Andro-L.A., Aveed, Delatestryl, Depo-Testosterone, Virilon

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • cancer

  • diabetes

  • heart disease

  • kidney disease

  • liver disease

  • lung disease

  • prostate disease

  • an unusual or allergic reaction to testosterone, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

Contact your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss a dose. Your doctor or health care professional will tell you when your next injection is due. Notify the office if you are unable to keep an appointment.

What may interact with this medicine?

  • medicines for diabetes

  • medicines that treat or prevent blood clots like warfarin

  • oxyphenbutazone

  • propranolol

  • steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. They will need to check the level of testosterone in your blood.

This medicine is only approved for use in men who have low levels of testosterone related to certain medical conditions. Heart attacks and strokes have been reported with the use of this medicine. Notify your doctor or health care professional and seek emergency treatment if you develop breathing problems; changes in vision; confusion; chest pain or chest tightness; sudden arm pain; severe, sudden headache; trouble speaking or understanding; sudden numbness or weakness of the face, arm or leg; loss of balance or coordination. Talk to your doctor about the risks and benefits of this medicine.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Testosterone injections are not commonly used in women. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Talk with your doctor or health care professional about your birth control options while taking this medicine.

This drug is banned from use in athletes by most athletic organizations.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breast enlargement

  • breathing problems

  • changes in emotions or moods

  • deep or hoarse voice

  • irregular menstrual periods

  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

  • stomach pain

  • swelling of the ankles, feet, hands

  • too frequent or persistent erections

  • trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • acne

  • change in sex drive or performance

  • facial hair growth

  • hair loss

  • headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Protect from light. Follow the directions for the product you are prescribed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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