To assess the efficacy and safety of a 300 mug/d testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women on concomitant estrogen therapy.
Five hundred ...thirty-three women with hypoactive sexual desire disorder who had undergone previous hysterectomy and bilateral oophorectomy were enrolled in a 24-week, multicenter, double-blind, placebo-controlled trial. Patients were randomly assigned to receive placebo or the testosterone patch twice weekly. The primary efficacy endpoint was change from baseline at week 24 in the frequency of total satisfying sexual activity, measured by the Sexual Activity Log. Secondary measures included sexual desire using the Profile of Female Sexual Function and personal distress as measured by the Personal Distress Scale. Hormone levels, adverse events, and clinical laboratory measures were reviewed.
Total satisfying sexual activity significantly improved in the testosterone patch group compared with placebo after 24 weeks (mean change from baseline, 1.56 compared with 0.73 episodes per 4 weeks, P = .001). Treatment with the testosterone patch also significantly improved sexual desire (mean change, 10.57 compared with 4.29, P < .001) and decreased personal distress (P = .009). Serum free, total, and bioavailable testosterone concentrations increased from baseline. Overall, adverse events were similar in both groups (P > .05). The incidence of androgenic adverse events was higher in the testosterone group; most androgenic adverse events were mild.
In surgically menopausal women with hypoactive sexual desire disorder, a 300 mug/d testosterone patch significantly increased satisfying sexual activity and sexual desire, while decreasing personal distress, and was well tolerated through up to 24 weeks of use.
To determine the prevalence of hypoactive sexual desire disorder (HSDD) among US women by reproductive status and age and to explore the correlates of sexually related distress.
The Women's ...International Study on Health and Sexuality questionnaire was mailed to a national sample of US women in 2000. The survey included validated questionnaires: the Short Form-36, which measures overall health status; the Profile of Female Sexual Function, which assesses sexual desire; and the Personal Distress Scale, which measures distress caused by low desire. Four groups of women were studied: surgically postmenopausal, aged 20 to 49 years and 50 to 70 years; premenopausal, aged 20 to 49 years; and naturally postmenopausal, aged 50 to 70 years. Clinically derived cutoff Profile of Female Sexual Function and Personal Distress Scale scores were used to classify women with HSDD and determine its prevalence. The relations between sexual desire and frequency of sexual activity or relationship satisfaction were assessed. Overall health status of HSDD women and women with normal desire were compared.
The prevalence of HSDD ranged from 9% in naturally postmenopausal women to 26% in younger surgically postmenopausal women. The prevalence of HSDD was significantly greater among surgically postmenopausal women, aged 20 to 49 years, than premenopausal women of similar age, whereas there were no significant differences in the prevalence between surgically postmenopausal women, aged 50 to 70 years, and naturally postmenopausal women. For many women, HSDD was associated with emotional and psychological distress as well as significantly lower sexual and partner satisfaction. HSDD was also associated with significant decrements in general health status, including aspects of mental and physical health.
HSDD is prevalent among women at all reproductive stages, with younger surgically postmenopausal women at greater risk, and is associated with a less active sex life and decreased sexual and relationship satisfaction.
Insufficient documentation exists regarding the prevalence of hypoactive sexual desire disorder (HSDD) in surgically menopausal (SM) women in European countries. Women who have undergone hysterectomy ...and bilateral oophorectomy experience a loss of ovarian hormones. Inclusion of these women in an epidemiological study provided the opportunity to study biological and cultural impacts on sexual function.
The aim of this study was to compare the prevalence of HSDD among SM women in France, Germany, Italy, and the United Kingdom, as well as the relationship between low sexual desire and sexual activity or behavior, and sexual or partner relationship satisfaction.
Cross-sectional survey of a convenience sample of 427 SM women aged 20–70 years.
The desire domain of the Profile of Female Sexual Function (PFSF) to identify women with low sexual desire, Personal Distress Scale (PDS) to measure distress caused by low sexual desire, and a sexual activities measure. Women with low sexual desire who were distressed were classified as having HSDD.
SM women having low sexual desire ranged from 35% (United Kingdom) to 44% (Italy); of these women, 16% (Germany) to 56% (France) were distressed because of their low sexual desire. Overall, SM women classified with HSDD ranged from 7% (Germany) to 22% (France). A strong positive correlation was observed between sexual desire and arousal, orgasm, and sexual pleasure in all countries (P < 0.001). Low sexual desire leads to less sexual activity, more dissatisfaction with sex life and partner relationship, and more negative emotional or psychological states, than normal desire in each country.
A similar percentage of SM women with low sexual desire were found across countries suggesting the role of biological factors (i.e., losing ovarian hormones) in determining sexual desire. Differences in the percentage of SM women with HSDD suggest a role for cultural factors in determining how low sexual desire is perceived. Graziottin A, Koochaki PE, Rodenberg CA, and Dennerstein L. The prevalence of hypoactive sexual desire disorder in surgically menopausal women: An epidemiological study of women in four European countries. J Sex Med 2009;6:2143–2153.
This article reports on a prevalence study of dementia and Alzheimer's disease among two groups of subjects with the same ethnic background but widely differing environments.
The study was conducted ...among residents aged 65 years and older in two communities: Yorubas (N = 2,494) living in Ibadan, Nigeria, and African Americans (N = 2,212 in the community and N = 106 in nursing homes) living in Indianapolis, Indiana. The study design consisted of a screening stage followed by a clinical assessment stage for selected subjects on the basis of their performance on the screening tests.
The age-adjusted prevalence rates of dementia (2.29%) and Alzheimer's disease (1.41%) in the Ibadan sample were significantly lower than those in the Indianapolis sample, both in the community-dwelling subjects alone (4.82% and 3.69%, respectively) and in the combined nursing home and community samples (8.24% and 6.24%, respectively). The prevalence rates of dementia and Alzheimer's disease increased consistently with advancing age in both study groups.
To the authors' knowledge, this is the first study, using the same research method at the two sites, to report significant differences in rates of dementia and Alzheimer's disease in two different communities with similar ethnic origins.
In this double-blind, placebo-controlled, 52-week trial among postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 μg of testosterone per day resulted in a ...significant although modest increase in the 4-week frequency of satisfying sexual episodes (1.4 more episodes per month), but the women were also subject to more adverse events, including androgenic side effects.
In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 '1;g of testosterone per day resulted in a significant although modest increase in the 4-week frequency of satisfying sexual episodes.
The literature suggests that the prevalence of sexual problems among women ranges from 9 to 43%.
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Among these women, hypoactive sexual desire disorder is a commonly reported, symptom-driven condition characterized by a decrease or absence of interest in sexual activity, causing distress.
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Decreased libido is common after natural menopause
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and bilateral oophorectomy.
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Several studies have shown the efficacy and short-term safety of a transdermal patch delivering 300 μg of testosterone per day for the treatment of hypoactive sexual desire disorder in women who have undergone either surgically induced or natural menopause and who use concomitant estrogen.
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Context: Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition.
...Objective: The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD.
Design: The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study).
Setting: The study was performed at private or institutional practices.
Patients: The subjects studied were women, aged 26–70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 μg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 μg/d testosterone group.
Intervention: Testosterone (300 μg/d) or placebo patches were applied twice weekly.
Main Outcome Measure(s): The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments.
Results: At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups.
Conclusion: In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.
Evaluation of the use of testosterone therapy for hypoactive sexual desire disorder (HSDD) after oophorectomy has mostly involved women treated with oral estrogen preparations. We investigated the ...efficacy and safety of a testosterone patch in surgically menopausal women receiving concurrent transdermal estrogen.
Women with HSDD after oophorectomy, for whom this was a concern, who were using transdermal estrogen, were recruited to a 24-week, randomized, double-blind, placebo-controlled trial in Europe and Australia. Patients were randomly allocated to placebo (n = 40) or testosterone 300 microg/day (n = 37) treatment. Primary endpoints were changes in sexual desire measured by the sexual desire domain of the Profile of Female Sexual Function and the frequency of satisfying sexual activity at 24 weeks.
Sixty-one women (79%) completed the trial. All subjects who received at least one application of study medication were included in analysis. The testosterone-treated group experienced a significantly greater change from baseline in the domain sexual desire score compared with placebo (change from baseline, 16.43 versus 5.98; P = 0.02). The domain scores for arousal, orgasm, decreased sexual concerns, responsiveness, and self-image as well as decreased distress were also significantly greater with testosterone therapy than placebo. The frequency of satisfactory sexual events increased but was not statistically different between treatment groups (P = 0.06) Adverse events occurred with similar frequency in both groups, and no serious risks of therapy were observed
In this study, transdermal testosterone therapy via a skin patch improved sexual desire and other sexual function domains. It was well tolerated in these oophorectomized women with HSDD receiving concomitant transdermal estrogen.
Postmenopausal women with hypoactive sexual desire disorder (HSDD) experienced statistically significant improvements in the frequency of satisfying sexual activity, sexual desire, and distress with ...testosterone treatment in phase III trials, but it was not known whether the magnitude of these effects was clinically meaningful. The clinical relevance study was designed to answer this question.
To evaluate the clinical relevance of the treatment benefits.
This study involved a representative sample of 132 surgically postmenopausal women with HSDD who were enrolled in two randomized, placebo-controlled trials (N=1094) assessing the efficacy and safety of transdermal testosterone treatment (300mcg/day) for 6months. At the end of the studies, prior to unblinding, a sample of women (12%) was interviewed concerning their experiences with the treatment.
Women were asked “Overall, would you say that you experienced a meaningful benefit from the study patches?” Changes in the efficacy end points in the double-blind studies were compared for the women who did and did not experience an overall meaningful benefit.
Overall, 33 of 64 women (52%) who received testosterone reported experiencing a meaningful treatment benefit, compared with 21 of 68 women (31%) who received placebo (P= 0.025). Among the women who identified themselves as experiencing a meaningful benefit, the mean (SE) change from baseline in 4-week frequency of satisfying sexual activity was 4.4 (0.76), in desire score was 21.0 (2.78), moving from “seldom” to “sometimes” feeling sexual desire, and in distress score was −36.5 (3.96), moving from “often” to “seldom” being distressed. Among the women who identified themselves as not experiencing a meaningful benefit, the mean (SE) change from baseline in 4-week frequency of satisfying sexual activity was 0.5 (0.31), in desire score was 2.9 (1.42), and in distress score was −8.8 (2.23).
Surgically menopausal women with HSDD in these studies received clinically meaningful benefits, including improvements in satisfying sexual activity, sexual desire, and personal distress. Kingsberg S, Shifren J, Wekselman K, Rodenberg C, Koochaki P, and DeRogatis L. Evaluation of the clinical relevance of benefits associated with transdermal testosterone treatment in postmenopausal women with hypoactive sexual desire disorder.
The Profile of Female Sexual Function (PFSF) is a patient-based instrument for the measuring of loss of sexual function in menopausal women with low libido (hypoactive female sexual desire disorder). ...The instrument, which contains 37 items in seven domains (sexual desire, arousal, orgasm, sexual pleasure, sexual concerns, sexual responsiveness, and sexual self-image) and a single-item measure of overall satisfaction with sexuality, has been extensively developed and initially validated in over 500 oophorectomized women with low libido in North America, Europe, and Australia. Initial validation results showed the PFSF is capable of discriminating these patients from age-matched controls and produced consistent responses and sensitivity across geographies. The objective of this nonrandomized, parallel-group study was to examine the psychometric properties of the final PFSF in an independent group of surgically menopausal women with low libido and to extend validation to naturally menopausal women with low libido. Participants from 16 study centers in North America included surgically (n = 59) and naturally (n = 88) menopausal women with low libido and their age-matched control subjects, both premenopausal (n = 57) and naturally menopausal (n = 47), who reported no problems with libido. Subjects completed the PFSF at baseline and again 4 weeks later. Adjusted mean scores for each of the seven domains were statistically significantly lower (P < 0.0001) in surgically menopausal women with low libido compared with age-matched control women, and in naturally menopausal women with low libido compared with naturally menopausal control women, demonstrating excellent discriminant validity. Test-retest reliability ranged from 0.57 to 0.91 for the seven domain scores, whereas internal-consistency reliability ranged from 0.74 to 0.95. Results of this research support the conclusion that the PFSF is a valid and reliable instrument for measurement of loss of sexual function in both naturally and surgically menopausal women with low libido.
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BFBNIB, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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