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.
Of the more than 40000 Americans killed each year in vehicular crashes, 40% are involved in alcohol-related collisions. Although self-reported alcohol use has become an anchor for alcohol ...intervention after traffic crashes, clinicians are often skeptical about the truthfulness of self-reporting.
To determine the validity of self-reported alcohol consumption of vehicular occupants hospitalized for a serious, alcohol-related injury.
Non-alcohol-dependent subjects 18 years and older who were injured in motor vehicle crashes were interviewed. The self-reported number of standard drinks, time that drinking commenced, sex, and weight were used to calculate estimated blood alcohol concentration. This value was compared with the blood alcohol concentration measured at admission.
Of the 181 subjects, 60% provided sufficient data to calculate the estimated concentration. Seven men with admission concentrations of 10 mg/dL or more denied drinking. Among the 113 subjects with estimated concentrations who acknowledged drinking (excluding the 7 who denied drinking), the mean concentration at admission was 158.67 mg/dL, and mean estimated concentration was 83.81 mg/dL. According to multiple regression analyses, weight and number of drinks accounted for 3% of the variance in alcohol concentration at admission for women (R=0.174, F2,40=0.623, P=.54) and for 29% of the variance in men (R=0.543, F2,128=26.71, P< .001).
Most persons who drink before vehicular injury acknowledge drinking. Self-reported data from men generally reflect the overall trend of alcohol consumption but with systematic underreporting. Reports from women are less predictable.
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.
Clinical assessment of androgen action and its correlation to testosterone levels in women has been challenging. The current gold standard for measuring biologically active testosterone (T) is serum ...free T by equilibrium dialysis. Alternative methods are desirable due to the cost, complexity, and limited availability of the equilibrium dialysis method. Salivary testing has been proposed as a possible substitute for serum testing. This study compared salivary versus serum measurements of total T (TT), bioavailable T (BT; consisting of free T FT and albumin-bound T), and FT from samples collected simultaneously in women who were either receiving transdermal T patch supplementation (300 microg/d) or a placebo patch.
Naturally and surgically postmenopausal women receiving concomitant hormone therapy were recruited to participate in a 24- to 52-week phase III trial of a 300 microg/day transdermal T patch for the treatment of hypoactive sexual desire disorder.
Initial analysis demonstrated high correlations between TT, BT, and FT levels (r = 0.776-0.855). However, there was no correlation with salivary T levels for any of the serum T subtypes (r = 0.170-0.261). After log transformation, salivary T correlated modestly with BT (r = 0.436, P < 0.001), FT (r = 0.452, P < 0.001), and TT (r = 0.438, P < 0.001).
Although salivary testing of T concentrations is an appealing alternative because it is inexpensive and noninvasive, our results do not support the routine use of salivary T levels in postmenopausal women.
To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause.
A multicenter, randomized, double-blind, ...placebo-controlled, parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin (N = 549). Women were randomized to receive testosterone 300 microg/day or placebo patches twice weekly for 24 weeks. The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period (weeks 21-24).
A total of 483 women (88%) were included in the primary analysis population (those with baseline sex hormone binding globulin levels < or = 160 nmol/L). The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo (participants with baseline sex hormone binding globulin levels < or = 160 nmol/L, mean change of 2.1 +/- 0.28 versus 0.5 +/- 0.23 episodes/4 weeks; P < 0.0001; intent-to-treat population, mean change from baseline of 1.9 +/- 0.26 versus 0.5 +/- 0.21 episodes/4 weeks, P < 0.0001). Testosterone also produced statistically significant improvements compared with placebo in all secondary efficacy measures, including sexual desire and personal distress. The testosterone patch was well tolerated.
Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire, decreased personal distress, and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder.
Purpose: To evaluate the safety of two doses of testosterone (T) administered by investigational transdermal matrix patch to women with impaired sexual function after surgical menopause.
Methods: ...Seventy-five women, aged 31–56 years, 1 to 10 years after TAH-BSO, received oral conjugated equine estrogens and, in random order, placebo, 150 μg T, and 300 μg T per day transdermally for 12 weeks each.
Results: Serum-free and bioavailable T increased to normal values with both T treatments. Dihydrotestosterone and total T increased to above normal with 300 μg T treatment, a finding related to higher than normal SHBG levels in women on oral estrogen. The hormones DHEA-S, estradiol, estrone, LH, FSH, and other safety parameters, hirsutism and acne scores, total cholesterol, HDL, LDL, triglycerides, hematocrit, platelets, WBC, bilirubin, AST, GGT, albumin, fasting glucose, insulin, heart rate, blood pressure, and hot flush frequency were not significantly affected by T treatment. Facial depilation rates (times/month) were similar for baseline (0.5), placebo (0.8) and 150 μg T (0.7) and rose slightly for 300 μg T (1.4). Adverse events during T and placebo treatments were comparable. One woman withdrew because of a skin reaction to the placebo patch; three others withdrew because of adverse events possibly or probably related to treatment.
Conclusion: Testosterone patches of 150 μg and 300 μg per day were well tolerated and raised T levels without affecting other sex hormones, lipids, blood counts, liver function, carbohydrate metabolism, vital signs, or hot flushes. No clinically significant virilization occurred. Longer, larger prospective clinical trials are planned.
In the Cincinnati area, a small subculture of natural childbirth practitioners and clients coexists with the dominant medical-model birth culture. The purposes of this research study were to explore ...how these two cultures coexist in this geographic area and to reveal more fully the essence and meaning of natural childbirth as a phenomenon of human experience. Madeleine Leininger's nursing theory of culture care diversity and universality and ethnonursing research method were used to explore the culture of the local natural childbirth community. In addition, aspects of heuristic inquiry, developed by Clark Moustakas, were used to study natural childbirth as a phenomenon of human experience. The data collected confirmed that the Cincinnati area has an active natural childbirth subculture with members who are united by beliefs that are important to their personal identities. Many kinds of interactions occurred between members of the natural childbirth community and the medical-model birth community, from comfortable collaboration to acrimony and mistrust. Formal dialogue between the two communities occurred infrequently, and a segment of the natural childbirth community operated chiefly in alternative settings like homes and an out-of-hospital birthing center. Common beliefs expressed by subculture members included that the responsibility for choices about childbirth belongs to the laboring woman; the fetus and mother should be seen as an organic whole; birth is a natural and healthy process which unfolds differently for each woman; technological and interventionist approaches to birth should be reserved for cases of medical necessity; and natural childbirth is a profound experience with long-lasting impact on women. Aspects of the natural childbirth experience that were identified by study participants included coping with pain, receiving support, entering into a particular kind of focused state, experiencing mastery, having difficulty communicating, depending on others, having religious feelings, loving their partners, and feeling anger at individuals who interfered with labor. To provide culturally congruent care to clients whose beliefs and desires originate in the natural childbirth subculture, nurses must understand that subculture and make collaborative changes in medical-model systems of care so that care acceptable to such clients can be achieved.
Because fetal alcohol syndrome (FAS), or fetal alcohol effects (FAE), is being diagnosed in growing numbers of children, there is more interest in their common characteristics and how they change ...throughout childhood. Few longitudinal studies that describe the common childhood course of FAS address appropriate interventions. Some literature exists that describes follow-up and support services needed by these children and their families. This article examines the common childhood course of FAS/FAE and the interventions and services needed to promote positive child and family health.
