Background/Purpose
It is important to confirm product use effects on skin health for products intended for prolonged skin contact. This study compared experimental and marketed reference adult ...incontinence protective underwear.
Methods
Randomized, single‐blind (examiner), parallel study evaluating skin health effects in predominantly obese incontinent women normally using protective underwear (approximately 20% Type II Diabetes). Subjects wore experimental or marketed reference protective underwear daily, 14 consecutive days. Visual skin grading, transepidermal water loss (TEWL) assessed before, after 1 and 2 weeks of product wear. Overall assessment of comfort assessed.
Results
Of the 122 subjects (60 experimental and 62 marketed reference), 22 were diabetic and 88 were postmenopausal. Under the conditions of this study, there were no statistically significant differences in overall change from baseline for visual grading and TEWL between the experimental product and the marketed reference product for all subjects. Changes from baseline for skin erythema and skin marking were generally small for both products for all subjects as well as for both diabetics and non‐diabetics. There were no serious adverse events (AEs), and no withdrawals due to AEs. Overall comfort assessments of size and fit were ‘just right,’ and skin comfort in the leg, waist and crotch areas were ‘comfortable’ or ‘very comfortable’ for both products.
Conclusions
In‐use 14‐day testing demonstrated few statistical differences between experimental product with unique odor neutralizing technology and currently marketed product for skin assessments and comfort. Both products were comfortable and well‐tolerated.
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.
Objective To evaluate the efficacy and safety of a transdermal testosterone patch (TTP, 300 μg/day) in naturally menopausal women with hypoactive sexual desire disorder (HSDD).
Methods A total of 272 ...naturally menopausal women, predominantly not using hormone therapy, were randomized in this 6-month, placebo-controlled, double-blind, multicenter study to receive twice weekly either TTP or an identical placebo. Efficacy endpoints measured were the 4-week frequency of satisfying sexual episodes (SSE) using the Sexual Activity Log, the sexual desire domain of the Profile of Female Sexual Function and distress by the Personal Distress Scale. Safety was assessed by adverse events, laboratory parameters and hormone levels.
Results The TTP group demonstrated significant improvements in SSE (p = 0.0089) as well as in sexual desire (p = 0.0007) and reduced personal distress (p = 0.0024) versus placebo at 6 months (intent-to-treat analysis, n = 247). The results were significant for all three endpoints in the subgroup (n = 199) not using hormone therapy. Similar numbers of women treated with placebo and TTP discontinued (n = 39, 27.5% vs. n = 26, 20%), reported adverse events (including application site reactions) (n = 101, 71.1% vs. n = 81, 62.3%) and withdrew due to adverse events (n = 20, 14.1% vs. n = 9, 6.9%). No clinically relevant changes were noted in laboratory parameters. Serum free and total testosterone levels increased from baseline in the TTP group (geometric means 5.65 pg/ml and 67.8 ng/dl, respectively, at week 24) within the physiological range; no changes were seen in estradiol and sex hormone binding globulin levels.
Conclusions TTP was effective in treating HSDD and improving sexual function in this study of naturally menopausal women with and without concurrent hormone therapy.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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.
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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The purpose of this study was to develop a self-administered, patient-based questionnaire to assess loss of sexual desire and associated symptoms in postmenopausal women with hypoactive sexual desire ...disorder (HSDD) experiencing distress.
Preliminary items and domains of sexual function were identified through individual and focus group interviews with postmenopausal women in the United States and Europe. A subset of items was selected for translation and further analysis. Cognitive interviews were conducted with women with HSDD and non-HSDD women in eight countries to ensure items would have the same meaning in seven languages. The resulting instrument was tested in 325 oophorectomized women with HSDD and 255 age-matched nonoophorectomized control women in the United States, Canada, Europe, and Australia.
Psychometric item reduction analyses resulted in 37 items organized into seven domains characterizing female sexual function in postmenopausal women with HSDD. Excellent reliability and validity of the domains of the Profile of Female Sexual Function (PFSF) were observed in all geographic areas tested. Statistically significant differences between oophorectomized women with low libido and control women were found for all domains and all geographic areas.
The PFSF is a new instrument specifically designed for measurement of sexual desire in oophorectomized women with low libido. Robust psychometric properties have been established in a large number of geographic regions and languages, making it useful for assessing therapeutic change in multinational clinical trials.
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.
Celotno besedilo
Dostopno za:
BFBNIB, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
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.
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