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Wulf H Utian

Publications and source records attributed to Wulf H Utian.

15 recordsLinked to original sources
PubMed2006

Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass.

UNLABELLED: The double-blind, randomized raloxifene alendronate comparison trial was the first study designed to compare two osteoporosis therapies head-to-head for fracture risk reduction. The original protocol planned to treat 3000 postmenopausal women with alendronate 10 mg/day (ALN) or raloxifene 60 mg/day (RLX) for 5 years, and to recruit women (50-80 years old) with a femoral neck bone mineral density (BMD) T-score between -2.5 and -4.0, inclusive, no prevalent vertebral fractures, and no prior bone-active agent use. The trial was stopped early, due to difficulty in finding treatment-naïve women to meet enrollment goals within the planned timeline, resulting in insufficient power to show non-inferiority between therapies in the primary endpoint (number of women with >or=1 new osteoporotic vertebral or nonvertebral fracture). Except for vertebral fractures, fracture analyses were based upon 1412 of the 1423 women randomized (mean age of 66 years). After 312+/-254 days (mean+/-SD), 22 women in the ALN group and 20 in the RLX group had new vertebral or nonvertebral fractures. Four women in the ALN group and none in the RLX group had moderate/severe vertebral fractures, a pre-specified endpoint (P=0.04). Lumbar spine, femoral neck, and total hip BMD were increased from baseline at 2 years in each group (P<0.001), with greater increases in the ALN group (each P<0.05). Similar numbers of women in each group had >or=1 adverse event and discontinued due to an adverse event. The only adverse events with an incidence that differed between groups were colonoscopy, diarrhea, and nausea; each was more common with ALN treatment (each P<0.05). One woman in each group had a venous thromboembolic event. One case of breast cancer occurred in each group. In summary, as this trial was terminated early, there was insufficient power to compare the fracture risks between alendronate and raloxifene. Safety profiles were as expected from clinical trial and post-marketing reports. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00035971.

Aged↗
PubMed2006

Vulvodynia: a state-of-the-art consensus on definitions, diagnosis and management.

Vulvodynia is a chronic pain syndrome affecting up to 18% of the female population. Despite its high prevalence and associated distress, the etiology, diagnosis and clinical management of the disorder have not been clearly delineated. This "white paper" describes the findings and recommendations of a consensus conference panel based on a comprehensive review of the published literature on vulvodynia in addition to expert presentations on research findings and clinical management approaches. The consensus panel also identified key topics and issues forfurther research, including the role of inflammatory mechanisms and genetic factors and psychosexual contributors.

Biomedical Research↗
PubMed2005

Comparative controlled trial of a novel oral estrogen therapy, estradiol acetate, for relief of menopause symptoms.

OBJECTIVE: To compare the efficacy and tolerability of a new oral estradiol prodrug, estradiol acetate, with micronized estradiol or conjugated equine estrogens for alleviation of postmenopausal vasomotor and urogenital symptoms. DESIGN: A total of 249 postmenopausal women experiencing seven or more moderate or severe vasomotor symptoms daily for 1 week or 60 or more symptoms in 1 week were randomized to 0.9 mg of estradiol acetate (n = 79), 1 mg of micronized estradiol (n = 85), or 0.625 mg of conjugated equine estrogens therapy (n = 85). Efficacy endpoints were the change in frequency and severity of vasomotor symptoms from baseline to week 12, participant-assessed urogenital symptoms, and investigator-assessed signs of vaginal atrophy. Efficacy results were considered equivalent if estradiol acetate was at least 80% as effective as estradiol and conjugated estrogens. RESULTS: At week 12, frequency of vasomotor symptoms decreased comparably in all groups, and at weeks 4 and 12, the decrease in frequency of symptoms was statistically equivalent for estradiol acetate and conjugated estrogens. Severity of vasomotor symptoms also improved comparably for all groups, with least squares mean decreases of 1.05 for estradiol acetate, 1.34 for estradiol, and 1.17 for conjugated estrogens at week 12. Urogenital symptoms and vaginal signs showed similar improvement in all groups. Overall, the majority of adverse events were mild or moderate and consistent with estrogen therapy. CONCLUSION: Estradiol acetate 0.9 mg was comparable to 1 mg of estradiol and 0.625 mg of conjugated equine estrogens in reducing the number and severity of vasomotor and urogenital symptoms in postmenopausal women. Oral estradiol acetate was well tolerated.

Adult↗
PubMed2005

Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review.

Many women experience vasomotor symptoms at or around the time of menopause. Hot flushes and night sweats are considered primary menopausal symptoms that may also be associated with sleep and mood disturbances, as well as decreased cognitive function. All of these symptoms may lead to social impairment and work-related difficulties that significantly decrease overall quality of life. Hot flushes have shown a great deal of variability in their frequency and severity in women. In some women, hot flushes persist for several months; in others, they may last for more than 10 years. Traditionally vasomotor symptoms were reported to begin 5 to 10 years prior to the cessation of the final menstrual cycle, corresponding with the initial decline in circulating gonadal hormones; however, night sweats in particular most often begin in perimenopause. The pathogenesis of hot flushes has not yet been fully elucidated, but the circuitry involving estrogen and neurotransmitters, norepinephrine and serotonin specifically, are hypothesized to play a major role in the altered homeostatic thermoregulatory mechanisms underlying these events. Menopause-associated vasomotor symptoms are associated with significant direct and indirect costs. Overall costs of traditional pharmacotherapy or complementary and alternative medicine modalities, including over-the-counter treatments and dietary supplements, for managing menopause-related vasomotor symptoms are substantial and include initial and follow-up physician visits and telephone calls. Additional costs include laboratory testing, management of adverse events, loss of productivity at work, and personal and miscellaneous costs. Pharmacoeconomic analyses, including those that consider risks identified by the Women's Health Initiative, generally support the cost-effectiveness of hormonal therapy for menopause-associated vasomotor symptoms, which have been the mainstay for the management of these symptoms for more than 50 years. However, because many women now want to avoid hormone therapy, there is a need for additional targeted therapies, validated by results from controlled clinical trials that are safe, efficacious, cost-effective, and well tolerated by symptomatic menopausal women.

Administration, Oral↗
PubMed2005

Assessment and management of women's sexual dysfunctions: problematic desire and arousal.

INTRODUCTION: Women frequently report low sexual desire or interest. An associated lack of subjective arousal during sexual activity is clinically highly apparent but has not been the focus of traditional sexual inquiry, definitions of dysfunction, or management. The frequent poor correlation of women's subjective sexual arousal and observable increases in genital congestion in response to sexual stimulation has not been reflected in assessment, diagnosis, or management. AIM: To provide recommendations/guidelines for the assessment and management of women's sexual dysfunctions focusing on low desire, low interest, and lack of arousal. METHODS: An international consultation, in collaboration with major sexual medicine associations, assembled over 200 multidisciplinary experts from 60 countries into 17 committees. One subcommittee of five members focused on women's sexual desire and arousal, developing over a 2-year period various recommendations. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based scientific literature, widespread internal committee discussion, public presentation, and debate. RESULTS: Women's sexual response in health can be reconceptualized as a circular model of overlapping phases of variable order influenced by psychological, societal, and biological factors. Subsequent revisions to definitions of arousal and desire disorder are given. Recommendations regarding assessment and management focus on factors reducing arousability and satisfaction. These include women's mental health and feelings for their partner, generally and at the time of sexual activity. Recommendations reflect the poor correlation of subjective arousal and increases in genital vasocongestion. CONCLUSION: Further outcome research of management based on new conceptualization of sexual response and revised definitions of dysfunction is needed. The basis of the variable correlation between genital vasocongestion and subjective arousal needs clarification as do the biological underpinnings of sexual response and their changes with age and life cycle.

Adult↗
PubMed2004

Relief of hot flushes with new plant-derived 10-component synthetic conjugated estrogens.

OBJECTIVE: A study was conducted to evaluate the safety and efficacy of 3 different doses of synthetic conjugated estrogens B, a new plant-derived 10-component conjugated estrogens product, for the treatment of menopausal vasomotor symptoms. METHODS: This was a randomized, double-blind, placebo-controlled trial. Highly symptomatic menopausal women (N = 281) received 12 weeks of a once-daily oral treatment with 0.3 mg, 0.625 mg, or 1.25 mg of 10-component synthetic conjugated estrogen or placebo. Patients recorded the daily frequency and severity of hot flushes. Statistical analyses compared results at weeks 4, 8, and 12 with baseline values. RESULTS: Statistically significant reductions (P <.05) in the frequency and severity of vasomotor symptoms were observed for all 3 dosage strengths of 10-component synthetic conjugated estrogen compared with placebo. The most commonly reported adverse events in all treatment groups were headaches. No difference in the incidence of treatment-related adverse events was seen between placebo and 10-component synthetic conjugated estrogen groups. CONCLUSION: The 0.3-mg, 0.625-mg and 1.25-mg dose strengths of 10-component synthetic conjugated estrogen significantly reduced the frequency and severity of vasomotor symptoms compared with placebo, and were well tolerated during this 12-week study. LEVEL OF EVIDENCE: I

Administration, Oral↗
PubMedDate not supplied

A methodology study to validate a structured diagnostic method used to diagnose female sexual dysfunction and its subtypes in postmenopausal women.

The currently accepted gold standard for diagnosis of female sexual dysfunction (FSD) is a nonstandardized interview by a clinician whose field of expertise is FSD. However, the limited number of experts in the field has implications for running efficient large-scale clinical trials. Therefore, we developed a structured diagnostic method (SDM) to enable diagnosis of FSD in postmenopausal women by health care professionals who are not FSD experts. Our study objectives were to evaluate both convergent validity and intrarater reliability of the SDM. The results showed that the method had good convergent validity and excellent intrarater reliability. Thus, we conclude that the SDM can reliably diagnose FSD status and FSD subtypes in postmenopausal women.

Coitus↗
PubMedDate not supplied

The Utian Quality of Life (UQOL) Scale: development and validation of an instrument to quantify quality of life through and beyond menopause.

OBJECTIVE: Quality of life (QOL) is an outcome variable requiring measurement in clinical care or pivotal regulatory trial research. Current menopause QOL measures are mostly life phase or disease symptom inventories or scores. Believing that QOL should refer more to "sense of well-being," we have developed the Utian QOL scale (UQOL) that is strongly based on perception of sense of well-being as distinct from menopausal symptoms. DESIGN: A pool of items sampling various aspects of well-being was developed. Peri- and postmenopausal women (n = 327) responded to the items, and their responses were subjected to a factor analysis. Four factors emerged, each representing a QOL domain. The resulting 23-item instrument was validated in a geographically and socioeconomically diverse sample of peri- and postmenopausal women using the Short Form-36, an established, frequently used QOL inventory. QOL domains were subjected to confirmatory factor analyses, formal item analysis was completed, and the measure was assessed for reliability and validity, including a second sample of women (n = 270). RESULTS: Women (n = 597; mean age, 52.9 years) from 12 communities across the United States completed the measure. The UQOL seems to reflect four components of QOL: occupational QOL, health QOL, emotional QOL, and sexual QOL. The questionnaire and scoring system are presented. CONCLUSION: We are reporting on the process of validating an instrument for quantifying sense of well-being in a perimenopausal population. Substantial reliability and validity estimates for the scale and its subscales support the UQOL as a valuable new tool for use in clinical research and practice.

Aged↗
PubMedDate not supplied

Effect of raloxifene on quality of life: a prospective study using the Utian Quality of Life (UQOL) Scale.

OBJECTIVE: The Utian Quality of Life Scale (UQOL) is a new questionnaire used to quantify patient perception of quality of life in postmenopausal women. The current study is the first to use the UQOL in ascertaining treatment effects on quality of life in postmenopausal women. DESIGN: This was a randomized, double-blind, placebo-controlled study of healthy postmenopausal women. Participants were randomized to raloxifene 60 mg/day or placebo. Participants completed the UQOL at baseline, at 3 months, and at the 6-month study endpoint. RESULTS: A total of 74 women (mean age, 55.6 years) were randomized. In the overall population, there were no significant changes from baseline to 6 months within or between treatment groups in any of the domains or total score, although raloxifene was associated with positive changes from baseline in the occupational (P = 0.093) and health (P = 0.055) domains. In women who completed the study, raloxifene was associated with a significant improvement from baseline in the occupational (P = 0.041) and health (P = 0.025) domains and in the total score (P = 0.044), whereas placebo had no effect. There were no statistically significant differences between raloxifene and placebo in any of the domains or total score. CONCLUSION: Although there were no treatment group differences, raloxifene was associated with an improvement from baseline in the occupational and health domains and in the overall score of the UQOL. Larger studies are needed using the UQOL as a primary endpoint to determine whether the positive effects of raloxifene on quality of life observed in this trial are real or a chance finding.

Adult↗
PubMedDate not supplied

Menopause and CME.

Explore the source record for details and available documents.

Education, Medical, Continuing↗
PubMedDate not supplied

Body mass index does not influence response to treatment, nor does body weight change with lower doses of conjugated estrogens and medroxyprogesterone acetate in early postmenopausal women.

OBJECTIVE: To determine the effects of lower doses of conjugated estrogens (CE) alone or in combination with medroxyprogesterone acetate (MPA) on body weight and to evaluate the influence of body mass index (BMI) on the effect of lower-dose CE or CE/MPA on vasomotor symptoms, vaginal atrophy, bone mineral density (BMD), endometrial safety, and side effects such as endometrial bleeding and breast pain. DESIGN: In this large clinical trial [the Women's Health, Osteoporosis, Progestin, Estrogen (Women's HOPE) study], 2,673 healthy, postmenopausal women with intact uteri were randomized for 1 year of CE 0.625, CE 0.625/MPA 2.5, CE 0.45, CE 0.45/MPA 2.5, CE 0.45/MPA 1.5, CE 0.3, CE 0.3/MPA 1.5 (all doses mg/d), or placebo. Weight, BMI, number and severity of hot flushes, vaginal atrophy (as determined by the vaginal maturation index), bleeding profiles, breast pain, and endometrial biopsies were evaluated. A subset of 822 women was randomized into a 2-year substudy to evaluate changes in BMD with lower-dose CE or CE/MPA regimens. RESULTS: After 1 year of treatment, a small but significant (P < 0.05) gain in body weight from baseline was observed in all arms of the study, the largest increase in body weight occurring in the placebo group [1.15 +/- 0.21 (SE) kg]. Body mass index had no significant effect on changes from baseline for vasomotor symptoms, bleeding patterns, vaginal atrophy, BMD, endometrial safety, or breast pain when analyzed both by analysis of covariance with baseline BMI as covariate or when participants were grouped into BMI less than 25 kg/m and BMI of 25 kg/m or greater. In placebo-treated women, vaginal atrophy was significantly greater (P < 0.05) in women with a BMI less than 25 kg/m compared with a BMI of 25 kg/m or greater. CONCLUSIONS: Lower- and standard-dose regimens of CE or CE/MPA are not associated with greater weight gain than placebo. In addition, BMI does not seem to influence effects of these regimens on vasomotor symptoms, vaginal atrophy, bleeding profiles, BMD, endometrial safety, or breast pain.

Body Mass Index↗