Long-term data for safety and benefit of testosterone therapy in women are lacking, but such data are required before long-term use of testosterone can be recommended. Similarly, safety data for the use of testosterone in nonestrogen replaced postmenopausal women are lacking and no recommendation for its use can be made currently. Nor can the supplementation of T to premenopausal women be recommended until such time there exist safety and efficacy data. Unfortunately, any enduring benefit after short-term treatment, although theoretically possible, is unproven. In addition, supplementing T on a temporary basis only, could have adverse effects on the couple if an improvement associated with T therapy is no longer apparent when it is withdrawn.
If despite the above, T supplementation is contemplated, careful assessment must establish absence of ongoing psychological (interpersonal, intrapersonal, contextual, and societal) and/or physical factors negatively affecting sexual interest and arousability. On the basis of available data, no specific testosterone regimen or dose can yet be recommended. The chosen formulation of testosterone must have pharmacokinetic data indicating that it produces blood levels within the normal premenopausal range. Achieving physiological free testosterone levels by transdermal delivery appears to be the best approach.
Contraindications to testosterone therapy include androgenic alopecia, seborrhea, or acne, hirsutism as well as a history of polycystic ovary syndrome, and estrogen depletion. Oral methyl testosterone therapy is contraindicated in women with hyperlipidemia or liver dysfunction. Regular follow up is both clinical—inspection of skin and hair for seborrhea, acne, hirsutism, and alopecia—and biochemical through monitoring of free/bioavailable testosterone and SHBG, keeping these values within the normal range for premenopausal women. Of note, methyl-T is not included in the usual assays for T. Possibly, the target level for older women should be even lower but this remains unclear. Lipid profile and glucose tolerance are also monitored. The current recommendation is to prescribe only for 12 months owing to lack of long-term safety data (92).
Tibolone is a synthetic steroid with tissue selective estrogenic, progestogenic, and androgenic actions. In use in Europe for more than 10 years, tibolone provides some relief from vasomotor symptoms (93), estrogen agonist activity on the vagina (94) and bone (95), but not on the endometrium (96). Tibilone was thought not to have estrogen agonist activity on breast tissue; but a recent, albeit nonrandomized but very large study of postmenopausal hormonal therapy showed a similar increase in breast cancer in women receiving tibolone and those receiving various combinations of estrogen and progestins (97). The typical ( presumed beneficial) estrogenic effects on lipids are not seen (98), but it is of note that tibolone does not promote (unwanted) coagulation (96). Prospective randomized trials comparing tibolone to placebo or to various formulations of estrogen and progestin therapy have been done. Although in most (99-101) but not all (102), there was significant improvement in sexual desire/interest in the women receiving tibolone; no study focused on sexually dysfunctional women. Recruitment centered on vasomotor symptoms or bone density. Studies in postmenopausal women with loss of arousability and therefore of sexual interest are needed.
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