Testosterone replacement for women

Testosterone replacement for women is as important as estrogen for bone loss, vasomotor, and libido concerns.

Traditionally thought of as the “male hormone,” testosterone plays a dramatic role in many aspects of a woman’s physiology and quality of life, including libido, sexual satisfaction, bone density, sense of well-being, vasomotor symptoms, and body composition.

INDIVIDUALIZED TREATMENT IS THE KEY

Almost every woman considers estrogen replacement at some point in her life, yet declining levels of androgens in menopausal and surgically menopausal women are generally overlooked by health care providers, in part because one-size-fits-all androgen replacement solutions are not currently available and promoted by the major pharmaceutical companies. Safe and effective low-dose androgen replacement therapies do exist, however, and should be considered as part of any program of natural hormone replacement.
“In the next few years, testosterone replacement will become as important for women as estrogen replacement”, says Marla Ahlgrimm, R.Ph. and CEO of Women’s Health America, Inc. “The good news for women and their health care providers is that Women’s Health America offers these options today!”
Dr. Elizabeth Barrett-Connor, world-renowned expert in menopause research and professor and chief of the division of epidemiology at the University of California, San Diego, School of Medicine, concurs and emphasizes the importance of individualized treatment. “Androgen, for some women, is the ‘missing hormone’ of their postmenopausal years. Hormone therapy should be tailored to each individual according to symptoms and combination estrogen-androgen therapy can be a significantly better option for some women than estrogen alone.”
As with all hormone replacement there is no one-size-fits-all. “Low-dose, individualized treatment is the key to effective androgen replacement,” says Ahlgrimm.

DOSAGE FORM IS AS IMPORTANT AS DOSAGE STRENGTH
Determining the right dosage form for a woman is as important as determining the right dosage strength. Transdermal patches, sublingual tablets, topical gels, and oral capsules can be prescribed and individually compounded for each patient. Baseline and follow-up testing of all major hormone levels is critical for maintaining hormone levels in a physiologic range and avoiding the side effects of overdosing. While synthetic testosterone tablets and injections have been used for women as far back as the 1930s, side effects including virilization, hirsutism, and acne were reported when high doses were administered. New studies validate that low-dose, bioidentical testosterone offers women the benefits of increased libido, decreased bone loss, and more, without adverse effects.

TRANSDERMAL TESTOSTERONE PATCH EFFECTIVE FOR HYSTERECTOMY PATIENTS
Loss of libido remains a common, untreated symptom in post-menopausal women, though several decades of studies universally show the effectiveness of androgen replacement on a number of parameters of sexuality. These include libido, frequency, satisfaction, pleasure, fantasy, and orgasm.
These studies include two clinical trials that support the effectiveness of a testosterone patch for improving libido.
Results of a study in Australia and Europe were recently announced at the 59th Annual Meeting of the American Society for Reproductive Medicine.1 Among 77 surgically menopausal women already on estrogen hormone replacement patches, sexual desire scores were 38% higher and there was a 42% increase in the frequency of total satisfying sexual activity at 24 weeks in women receiving a testosterone patch over placebo. The patch also significantly improved orgasm, sexual arousal, sexual responsiveness, and sexual self-image and reduced feelings of distress.
In another recent study conducted at Cedars-Sinai Medical Center, 447 surgically menopausal women receiving oral estrogen who reported low sexual desire were randomized to receive a placebo patch or one of three doses of transdermal testosterone.2 Results showed the testosterone patch at all doses significantly increased sexual desire. One dosage group experienced a 30% increase in frequency of total satisfying sexual activity vs. placebo (p<0.05) and an 81% increase vs. baseline (p<0.05). This group also experienced a 66% increase in sexual desire vs. baseline (p<0.05) and a significant increase vs. placebo (p<0.05). These results were announced at the 14th Annual Meeting of The North American Menopause Society.

SUBLINGUAL TESTOSTERONE AND HRT TABLET ALSO EFFECTIVE
In a double-masked, randomly assigned, placebo-controlled crossover design, Tuiten et al. examined whether administration of a single dose of testosterone to sexually functional women increases vaginal and subjective sexual arousal when they are exposed to erotic visual stimuli3.
The study found there is a time lag in the effect of sublingually administered testosterone on genital responsiveness in women. The increase in genital responsiveness was found to be three to four and one-half hours after reaching peak testosterone levels. In addition, a consecutive increase in vaginal arousal might cause higher genital sensations and sexual lust.
In another double-blind, prospective study of post-menopausal women conducted at New Britain Hospital in Connecticut and reported by The North American Menopause Society, subjects were divided into two groups to test the effectiveness of sublingual HRT with and without testosterone. Results showed all sublingual micronized HRT favorably decreased serum and urine markers of bone metabolism, prevented bone loss, and resulted in an increase in spine and hipbone mineral density.4 In the HRT + T group receiving micronized testosterone (1.25 mg) in addition to estradiol (0.5 mg) plus micronized progesterone (100 mg) twice daily, the addition of testosterone for one year resulted in a statistically significant increase in hipbone mineral density.

ADDITIONAL BENEFITS AND RISKS OF TESTOSTERONE REPLACEMENT IN WOMEN
Other studies show that androgen replacement may have a variety of other benefits for woman including relieving depression,5 improving body composition,6 and relieving vasomotor symptoms.7
Current clinical evidence indicates that reported risks of virilization and hirsutism associated with androgen replacement were based on high dosing and are readily reversible with a reduction in dose. Timmons et al. reported there was no increase in incidence of hirsutism in their two-year study of those taking estrogen replacement or androgen and estrogen replacement therapy.8

Did you know… Women’s Health America offers individually compounded, low-dose, bio-identical hormone dosage options including the transdermal patch, sublingual tablet, topical gel, and oral capsule.

CLINICAL CHALLENGE: CASE-IN-POINT

Menopausal woman using estrogen therapy still has complaint of low libido, hot flashes, and high rate of bone loss.
A 51-year-old menopausal woman using estrogen patch therapy, who was complaining of loss of libido and ongoing hot flashes, was referred to Barbara Reineke, Nurse Practitioner at Women’s Health America.
A saliva “free” hormone assessment revealed low testosterone and estradiol levels in addition to the expected low progesterone level. Her urine NTx Bone Resorption test result was >100 (normal <38 nM BCE), indicating a high rate of bone breakdown.

THE PHARMACY SOLUTION:

BiEst 2.5mg and Testosterone 4mg oral capsule daily AND Progesterone 300mg Even Release Tablet at bedtime.
The prescription above was written for the patient, however, other customized prescription considerations for this patient included the use of a sublingual estradiol and progesterone tablet with a transdermal testosterone patch, an approach that could be used if the initial prescription resulted in androgen side effects.
Upon a six-month follow-up assessment, the patient described a 25% – 50% improvement in libido and resolution of hot flashes without side effects. Urine NTx indicated a decreased rate of bone breakdown to 21 (normal <38 nM BCE).

References:

1Efficacy and safety of testosterone patches for the treatment of low sexual desire in surgically menopausal women. Abstract O-199.
2Roy S et al. Surgically menopausal women reported significant increase in frequency of total satisfying sexual activity. Proceedings of the N Am Menopause Soc 2003, Miami Beach.
3Tuiten A, Van Honk J, Koppeschaar H, Bernaards C, Thijssen J, Verbaten R. Time course of effects of testosterone administration on sexual arousal in women. JAMA, The Journal of the American Medical Association, 2000; 19:2504.
4Miller BE, De Souza MJ, Slade K, Luciano AA. Sublingual administration of micronized estradiol and progesterone, with and without micronized testosterone: effect on biochemical markers of bone metabolism and bone mineral density. Menopause: The Journal of the North American Menopause Society 2000; 5:318-326.
5Rohr UD. The impact of testosterone imbalance on depression and women’s health. Maturitas 2002; 41:S25-46.
6Davis SR, McCloud PI, Strauss BJG, Burger HG. Testosterone enhances estradiol’s effects on post-menopausal bone density and sexuality. Maturitas 1995; 21:227-36.
7Simon JA, Klaiber E, Wiita B, Ynag HW, Artis A. Double-blind comparison of two doses of estrogen and estrogen-androgen therapy in naturally postmenopausal women: neuroendocrine, psychological and psychosomatic effects. Fertil Steril 1996; 66:S71.
8Timmons MC, Young R, Barrett-Connor E et al. Interim safety analysis of a two-year study comparing oral estrogen-androgen and conjugated estrogens in surgically menopausal women. Proceedings of the N Am Menopause Soc 1995; San Francisco

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