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Biomedical subjects

Raymond C Rosen

Publications and source records attributed to Raymond C Rosen.

At least 19 recordsLinked to original sources
PubMed2006

Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials.

BACKGROUND: No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation. METHODS: We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094. FINDINGS: 672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0.0001, all doses vs placebo). Mean IELT at baseline was 0.90 (SD 0.47) minute, 0.92 (0.50) minute, and 0.91 (0.48) minute, and at study endpoint (week 12 or final visit) was 1.75 (2.21) minutes for placebo, 2.78 (3.48) minutes for 30 mg dapoxetine, and 3.32 (3.68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8.7%, 20.1%), diarrhoea (3.9%, 6.8%), headache (5.9%, 6.8%), and dizziness (3.0%, 6.2%). INTERPRETATION: On-demand dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation.

Adult↗
PubMed2006

The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities, and professional help-seeking.

OBJECTIVES: This study evaluated the associated comorbidities and patient satisfaction with treatment options for premature ejaculation (PE), a common sexual dysfunction. METHODS: A comprehensive, Internet-based survey (the PE Prevalence and Attitudes [PEPA] survey) was conducted among men ages 18-70 in the United States, Germany, and Italy (n=12,133). Men were classified as having PE based on self-report of low or absent control over ejaculation, resulting in distress for them or their sexual partner or both. RESULTS: The prevalence of PE was 22.7% (24.0% in the United States, 20.3% in Germany, and 20.0% in Italy) and did not vary significantly with age among men over age 24 yr. Men with PE were more likely to self-report other sexual dysfunctions (e.g., anorgasmia, low libido, erectile dysfunction) and psychological disturbances (e.g., depression, anxiety, excessive stress) than men without PE (p<0.05 for all). Men with PE were most aware of (>70%) and most likely to have used (>50%) special positions during sex, interrupted stimulation, masturbation, and having intercourse more often than usual to manage their PE. Only 9.0% of men with PE reported having consulted a physician for the condition; 81.9% had to initiate the conversation about PE and 91.5% reported little or no improvement as a result of seeking treatment. CONCLUSION: PE is a highly prevalent sexual problem, with significant sexual and psychological comorbidities. Most men with PE do not seek assistance from their physician, and most of those who do are not satisfied with the results.

Adolescent↗
PubMed2006

Erectile dysfunction and cardiac disease: recommendations of the Second Princeton Conference.

Erectile dysfunction (ED) has been linked increasingly to cardiovascular risk factors and comorbidities. Considering the potential risk associated with sexual activity, guidelines were developed (Princeton I) for assessment and management of patients with varying degrees of cardiac risk. These guidelines were recently updated (Princeton II) based on new data concerning the link between ED and cardiovascular disease and the availability of additional phosphodiesterase type 5 inhibitors (vardenafil, tadalafil). Despite the need for careful risk assessment in all cases, sexual activity remains safe for the large majority of patients. However, all patients presenting with complaints of ED should be carefully assessed for the presence of cardiovascular risk factors (eg, obesity, hypertension, hyperlipidemia). Risk-factor modification, including lifestyle interventions (eg, exercise, weight loss) is strongly encouraged. Guidelines are presented for the management of acute coronary syndromes in patients taking phosphodiesterase type 5 inhibitors, including alternatives to the use of nitrates for these patients. Other drug interactions and the cardiovascular safety of testosterone replacement therapy are considered.

Cardiovascular Diseases↗
PubMed2006

Normal sexual response in women.

In summary, women's sexual response is characterized as highly variable and influenced by a wide range of determinants, including physiologic, psychosocial, and contextual factors. This complexity is reflected also in the multiple etiologic factors and determinants of sexual problems in women. It is evident in current conceptualizations of normal female sexual response, as presented in this article, in which the circularity and overlap of different components and aspects of sexual response in women are viewed differently from the more linear and invariable trajectory of sexual response in men. It is not surprising, therefore, that treatments that target limited physiologic aspects of women's sexual response, such as PDE-5 inhibitors and other vasoactive agents, have demonstrated little overall effectiveness in treating women's sexual dysfunctions [21, 22]. Rather there is consensus at present regarding the need for a more holistic or biopsychosocial approach to management of sexual dysfunction in women. Clearly the roles of psychologic and interpersonal determinants need to be taken into account in this approach. Perhaps most important and especially relevant for treating female sexual dysfunction is the emphasis on interpersonal factors as contributors to the ultimate sexual satisfaction of women. Clinicians should be especially mindful of this influence when addressing women's sexual problems. Another implication of this research is the need for broader definitions and conceptualization of sexual dysfunction in women. Current diagnostic definitions of female sexual dysfunction are based largely on the traditional sexual response cycle models of Masters and Johnson [7] and Kaplan [9]. With the development of new models and concepts of normal sexual response in women, it is increasingly necessary for new definitions and concepts of sexual dysfunction to be developed. Promising efforts have been made in this regard, although much work remains to be done.

Arousal↗
PubMed2006

Research instruments for the diagnosis and treatment of patients with erectile dysfunction.

As the incidence and prevalence of erectile dysfunction (ED) increase, healthcare providers will require robust, accurate, and efficient tools for appropriately diagnosing and treating patients with ED. Moreover, clinicians will need effective follow-up tools that assess treatment efficacy and satisfaction, to help patients meet their expectations for successful treatment of ED. We provide a summary of some of the most commonly used instruments for the diagnosis and assessment of ED treatment efficacy that will be referred to in this supplement.

Diagnostic Techniques, Urological↗
PubMed2006

Assessment of sexual dysfunction in patients with benign prostatic hyperplasia.

Sexual dysfunction is a highly prevalent condition in ageing men that considerably affects their quality of life, although it is a frequently neglected aspect of healthcare. The main predictors of sexual dysfunction are age and cardiovascular comorbidities such as hypertension, heart disease, hypercholesterolaemia and diabetes. Recently, the severity of lower urinary tract symptoms (LUTS) has also been identified as a crucial risk factor for sexual dysfunction, independent of age and comorbidities. Despite the increased prevalence of sexual dysfunction with age, health-related problems and psychological factors, there is evidence that many older men remain sexually active. Currently available self-administered questionnaires assessing male sexual dysfunction focus almost exclusively on erectile function. There is evidence from recent large-scale epidemiological studies that ejaculatory dysfunction (EjD) is almost as prevalent as erectile dysfunction (ED), affecting nearly half of men aged > or = 50 years. Other domains such as orgasm, desire, and satisfaction with sex life are important and should be considered. There is thus a need to develop and validate more comprehensive and multidimensional instruments for assessing sexual dysfunction in ageing men. A new instrument, the Male Sexual Health Questionnaire (MSHQ), was developed and validated to assess these specific aspects of male sexual dysfunction . It consists of a 25-item self-administered questionnaire including three core domains (erection, ejaculation, satisfaction with sex life) and additional items related to sexual activity, desire and bother related to sexual dysfunction. The MSHQ scale has excellent psychometric properties and is well suited for use in clinical and research settings. A short form of the MSHQ scale is currently under development.

Aged↗
PubMed2006

The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine.

INTRODUCTION: Erectile dysfunction (ED) is a highly prevalent disorder associated with a significant burden of illness. The prevalence and incidence of ED are strongly age-related, affecting more than half of men >60 years. The first Princeton Consensus Conference (Princeton I) in 1999 developed guidelines for safe management of cardiac patients regarding sexual activity and the treatment of ED. AIM: The second conference (Princeton II) was convened to update the recommendations based on the expanding knowledge base and new treatments available. This article reviews and expands on the Princeton II guidelines to address sexual dysfunction and cardiac risk. METHODS: A consensus panel of experts reviewed recent multinational studies in safety and drug interaction data for three phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. RESULTS: Erectile dysfunction is an early symptom or harbinger of cardiovascular disease, due to the common risk factors and pathophysiology mediated through endothelial dysfunction. Major comorbidities include diabetes, hypertension, hyperlipidemia and heart disease. Any asymptomatic man who presents with ED that does not have an obvious cause (e.g., trauma) should be screened for vascular disease and have blood glucose, lipids, and blood pressure measurements. Ideally, all patients at risk but asymptomatic for coronary disease should undergo an elective exercise electrocardiogram to facilitate risk stratification. Lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease, is literature-supported. CONCLUSIONS: The recognition of ED as a warning sign of silent vascular disease has led to the concept that a man with ED and no cardiac symptoms is a cardiac (or vascular) patient until proven otherwise. Men with ED and other cardiovascular risk factors (e.g., obesity, sedentary lifestyle) should be counseled in lifestyle modification.

Adult↗
PubMed2006

Psychosocial outcomes and drug attributes affecting treatment choice in men receiving sildenafil citrate and tadalafil for the treatment of erectile dysfunction: results of a multicenter, randomized, open-label, crossover study.

INTRODUCTION: Although sildenafil citrate (sildenafil) and tadalafil are efficacious and well-tolerated treatments for erectile dysfunction (ED), preference studies have shown that patients may favor one medication over the other. AIM: To determine whether psychosocial outcomes differed when men with ED received tadalafil compared with sildenafil. MAIN OUTCOME MEASURES: Measures included a treatment preference question, Psychological and Interpersonal Relationship Scales (PAIRS), and Drug Attribute Questionnaire. METHODS: Randomized, open-label, crossover study. After a 4-week baseline, men with ED (N = 367; mean age = 54 years; naïve to type 5 phosphodiesterase inhibitor therapy) were randomized: tadalafil for 12 weeks then sildenafil for 12 weeks or vice versa (8-week dose optimization/4-week assessment phases). During dose optimization, patients started with 10 mg tadalafil, or 25 or 50 mg sildenafil and could titrate to their optimal dose (10 or 20 mg tadalafil; 25, 50, or 100 mg sildenafil). Medications were taken as needed. Patients completing both 12-week periods chose which medication to continue during an 8-week extension. RESULTS: Of 291 men completing both treatment periods, 71% (N = 206) chose tadalafil and 29% (N = 85) chose sildenafil (P < 0.001) for the 8-week extension. When taking tadalafil compared with sildenafil men had higher mean endpoint scores on PAIRS Sexual Self-Confidence (tadalafil = 2.91 vs. sildenafil = 2.75; P < 0.001) and Spontaneity (tadalafil = 3.32 vs. sildenafil = 3.17; P < 0.001) Domains and a lower mean endpoint score on Time Concerns Domain (tadalafil = 2.2 vs. sildenafil = 2.59; P < 0.001). The two most frequently chosen drug attributes to explain treatment preference were ability to get an erection long after taking the medication and firmness of erections. Tadalafil and sildenafil were well tolerated with 12 (3.3%) patients discontinuing for an adverse event. CONCLUSIONS: As measured with PAIRS, men with ED had higher sexual self-confidence and spontaneity and less time concerns related to sexual encounters when treated with tadalafil compared with sildenafil. These psychosocial outcomes may help explain why more men (71%) preferred tadalafil for the treatment of ED in this clinical trial.

Adult↗
PubMed2006

An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.

INTRODUCTION: Melanocortins affect multiple physiological responses, including sexual behaviors. Bremelanotide is a synthetic peptide melanocortin analog of alpha-melanocyte-stimulating hormone that is an agonist at melanocortin receptors MC3R and MC4R. AIM: To evaluate a single intranasal dose of bremelanotide for potential effects on physiological and subjective measurements of sexual arousal and desire in premenopausal women with sexual arousal disorder. MAIN OUTCOME MEASURES: Change in vaginal pulse amplitude during neutral and erotic videos after treatment with bremelanotide or placebo and subjects' perceptions of physiological and sexual response within 24 hours of treatment with bremelanotide or placebo. METHODS: Eighteen premenopausal women with a primary diagnosis of female sexual arousal disorder were randomly assigned to receive a single intranasal dose of 20 mg bremelanotide or matching placebo in a double-blind manner during the first in-clinic treatment session, and the alternate medication during the second in-clinic treatment session. During each session, subjects viewed a 20-minute neutral video followed by a 20-minute sexually explicit video. Vaginal photoplethysmography was used to monitor vaginal vasocongestion and questionnaires were used to evaluate perceptions of sexual response within the following 24-hour period. RESULTS: More women reported moderate or high sexual desire following bremelanotide treatment vs. placebo (P = 0.0114), and a trend toward more positive responses regarding feelings of genital arousal occurred after bremelanotide compared with placebo (P = 0.0833). Among women who attempted sexual intercourse within 24 hours after treatment, significantly more were satisfied with their level of sexual arousal following bremelanotide, compared with placebo (P = 0.0256). Vaginal vasocongestion did not change significantly while viewing erotic videos following bremelanotide administration compared with placebo. CONCLUSION: This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at-home study.

Adult↗
PubMed2006

The Bolger conference on PDE-5 inhibition and HIV risk: implications for health policy and prevention.

INTRODUCTION: Recent reports have linked the use of phosphodiesterase type 5 (PDE-5) inhibitors with increased rates of high-risk sexual behavior and HIV transmission in some individuals. AIM: A National Institute of Mental Health (NIMH)-funded, multidisciplinary conference was convened to evaluate scientific research, clinical and ethical considerations, and public policy implications of this topic. MAIN OUTCOME MEASURES: Published and unpublished findings on effects of PDE-5 inhibitors on sexual behavior; published guidelines and management recommendations. METHODS: Leading investigators in relevant disciplines (e.g., public health, epidemiology, medical ethics, urology, psychology) participated in a 2-day meeting, including representatives of government, scientific, and regulatory agencies (the Centers for Disease Control, Food and Drug Administration, NIMH, and the National Institute on Drug Abuse). Panelists provided critical reviews of substantive areas of research, followed by question and answer sessions on each topic. On the second day, working groups were convened to identify critical gaps and priorities in three major areas: (i) research and evaluation needs; (ii) prevention strategies and clinical management issues; and (iii) policy and prevention implications. RESULTS: Research needs and priorities were categorized into four specific areas: (i) basic and clinical/laboratory research; (ii) epidemiology and risk factors; (iii) social-behavioral processes and interventions; and (iv) prevention/policy and educational needs. Identified gaps in the available data include populations at risk (e.g., risk among heterosexuals, risk profiles among subpopulations of men who have sex with men) and the specific role of PDE-5 inhibitors in HIV seroconversion. Specific areas of emphasis were the need for safer sex counseling, comprehensive sexually transmitted infection (STI) screening and follow-up when indicated, avoidance of potentially dangerous drug interactions, and potential benefits of testosterone replacement for HIV-positive men with decreased androgen and other symptoms of hypogonadism. Conclusions. A conference was convened on the topic of PDE-5 inhibition and HIV risk. This "white paper" summarizes the findings of the conference and recommendations for future research.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2006

Update on the relationship between sexual dysfunction and lower urinary tract symptoms/benign prostatic hyperplasia.

PURPOSE OF REVIEW: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) is a condition that commonly affects older men and is often associated with sexual dysfunction. Recent evidence of an association between LUTS/BPH and sexual dysfunction will be reviewed, as well as the effects of pharmacological treatment options for symptomatic LUTS/BPH on sexual function. RECENT FINDINGS: Large-scale epidemiological studies conducted worldwide have provided strong evidence for an association between LUTS, erectile dysfunction and ejaculatory dysfunction. In multivariate analyses controlling for age, comorbidities, and lifestyle factors, LUTS have been clearly demonstrated to be an independent risk factor for erectile and ejaculatory dysfunction. Various pathophysiological mechanisms have been proposed for the association between LUTS and male sexual dysfunction. These include autonomic hyperactivity, alterations in Rho/Rho kinase pathway, endothelial (nitric oxide synthase/nitric oxide) dysfunction, pelvic ischemia, and age-related hormone imbalances. Owing to the link between LUTS/BPH and male sexual dysfunction, patients presenting with one of these conditions should be routinely screened for the other condition. In addition, because medical and surgical treatments for LUTS/BPH are commonly associated with sexual side effects, patients with LUTS/BPH should be monitored for treatment-related sexual outcomes. SUMMARY: LUTS/BPH is an independent risk factor for sexual dysfunction in aging men. Further studies are needed to define the mechanism(s) underlying the link between LUTS/BPH and male sexual dysfunction. Additional studies of combination therapy for LUTS/BPH, sexual dysfunction, and other age-associated comorbidities are needed to establish new approaches to the optimal management of these conditions in aging men.

Adrenergic alpha-Antagonists↗
PubMed2005

Lifestyle management of erectile dysfunction: the role of cardiovascular and concomitant risk factors.

The influence and significance of lifestyle factors in erectile dysfunction (ED) have been demonstrated in cross-sectional and prospective, randomized, controlled trials. Recent epidemiologic studies in several countries have shown that modifiable lifestyle or risk factors, including physical activity in particular, are directly related to the occurrence of ED. In this article, we review several recent observational studies, 2 of which include a longitudinal follow-up component in the study design. The levels of physical activity in both of these studies predicted ED prevalence and incidence. Furthermore, the role of lifestyle changes (weight loss, physical activity) were recently demonstrated to be effective in modifying ED in a prospective, randomized Italian trial in moderately obese, sedentary men. Men without overt diabetes mellitus or cardiovascular disease participated in this landmark study. Other studies have shown that aggressive management of cardiovascular risk factors can increase the effectiveness or outcomes associated with pharmacologic management of ED. Taken together, these studies support the value of risk factor modification and lifestyle change in the clinical management in men with ED and concomitant cardiovascular illness.

Cardiovascular Diseases↗
PubMed2005

Sexual dysfunction and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Sexuality is an essential aspect of a couple's relationship and has a significant impact on life satisfaction. Benign prostatic hyperplasia (BPH) is a condition that commonly affects older men and is often associated with lower urinary tract symptoms (LUTS) and sexual dysfunction. Men with moderate-to-severe LUTS are at increased risk for sexual dysfunction, including moderate-to-severe erectile dysfunction (ED), ejaculatory dysfunction (EjD), and hypoactive desire (HD). The results of several recent large-scale studies have shown a consistent and strong relationship between LUTS and both ED and EjD. It appears that the pathophysiological mechanisms of LUTS and the related prostatic enlargement of BPH as well as certain treatments for this condition may have an impact on both the erection and ejaculation components of the sexual response. Validated questionnaires that assess sexual function provide clinicians with valuable information to help guide treatment selection decisions. Effective medical therapies for LUTS associated with BPH include alpha(1)-adrenergic receptor antagonists (i.e., alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-reductase inhibitors (i.e., finasteride and dutasteride). The side effects of these medications, including sexual dysfunction, are important distinguishing features. The successful management of patients with LUTS associated with BPH should include assessments of sexual function and monitoring of medication-related sexual side effects. For men with LUTS and sexual dysfunction, an appropriate integrated management approach, based on each patient's symptoms and outcome objectives, is warranted.

Humans↗
PubMed2005

Epidemiology of erectile dysfunction: the role of medical comorbidities and lifestyle factors.

Erectile dysfunction (ED) is a highly prevalent condition in aging men with significant interpersonal and psychosocial consequences. Large-scale epidemiologic studies have demonstrated a consistent age-related loss of erectile function in men from different geographic and ethnic backgrounds, with approximately half of men over 70 years of age reporting moderate to severe symptoms. ED is associated strongly with specific comor-bidities, such as cardiovascular disease and hypertension, diabetes mellitus, lower urinary tract symptoms, prostate cancer, and depression. Lifestyle factors, including obesity and exercise frequency, also have been implicated in recent studies.

Adult↗
PubMed2005

Sexual experience of female partners of men with erectile dysfunction: the female experience of men's attitudes to life events and sexuality (FEMALES) study.

INTRODUCTION: Much research has explored the experience of erectile dysfunction (ED) among men with ED, but far less attention has been paid to the perceptions and sexual experiences of the female partners of men with ED. AIM: The objective of this study was to characterize the attitudes, beliefs, and sexual experience of female partners of men with erectile difficulties. METHODS: Female partners of men with ED who had participated in the Men's Attitudes to Life Events and Sexuality (MALES) study were recruited for this research via mail or Internet, after their male partners consented to this contact. Female partners of men with ED (N = 293) responded to questionnaire measures assessing their frequency of sexual activity and the nature of their sexual experience, both before and after the development of their partner's ED, and in relation to their partner's use of phosphodiesterase type 5 (PDE5) inhibitors. RESULTS: Women reported engaging in sexual activity significantly less frequently after their partner developed ED in comparison with before (P < 0.001). Moreover, significantly fewer women experienced sexual desire, arousal, or orgasm "almost always" or "most times," and significantly fewer women reported satisfaction with their sexual relationship after their partner developed ED, compared with before (P < 0.001). Decreases in female sexual satisfaction and frequency of orgasm were significantly related to the male partner's self-reported severity of ED (P < 0.01). The proportion of women who experienced sexual desire, arousal, and orgasm "almost always" or "most times" was significantly higher in the group whose partners were currently using a PDE5 inhibitor (P < 0.05). CONCLUSION: Erectile dysfunction has significant adverse effects on the female partner's sexual experience. Women with partners who were currently using PDE5 inhibitors had a more satisfying sexual experience than those whose partners did not use a PDE5 inhibitor.

Adult↗
PubMed2005

Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil.

INTRODUCTION: Erectile dysfunction (ED) has a dual negative impact on men and their female partners; both are likely to face a drop in sexual quality of life and challenges to their intimate relationship as couples' sexual activities are curtailed by the loss of erectile function. AIM: The primary objective of this study was to compare the efficacy of vardenafil vs. placebo in terms of success of maintenance of erection in men with ED and improvement of their female partner's sexual quality of life. METHODS: This was a randomized, double-blind, multicenter, flexible-dose, parallel-group comparison of vardenafil vs. placebo for 12 weeks in men (> or =18 years) with ED of > or = 6 months duration, and their female partners. MAIN OUTCOME MEASURES: Changes in patient's overall response rate to Sexual Encounter Profile question 3 (SEP3) "Did your erection last long enough for you to have sexual intercourse?" and female partner's response to the quality of life domain of the modified Sexual Life Quality Questionnaire (mSLQQ-QOL) at last observation carried forward (LOCF) were considered the primary efficacy measures. In addition, patient's response to SEP2 "Were you able to insert your penis into your partner's vagina?," the erectile function domain of the International Index of Erectile Function (IIEF-EF) and patient's mSLQQ-QOL score were also assessed. RESULTS: Compared with placebo, vardenafil significantly improved overall least square (LS) mean per-patient SEP3 success rate (28% vs. 68%; P < 0.0001) and partner's LS mean (standard error [SE]) mSLQQ-QOL score at LOCF (32.14 [3.24] vs. 65.80 [3.10]; P < 0.0001). In addition, compared with placebo, vardenafil also improved overall LS mean per-patient SEP2 success rate (47% vs. 80%; P < 0.0001), LS mean (SE) IIEF-EF scores at LOCF (12.7 [0.8] vs. 22.8 [0.8]; P < 0.0001) and patient's LS mean (SE) mSLQQ-QOL (28.37 [3.46] vs. 63.85 [3.28]; P < 0.0001) at LOCF. CONCLUSIONS: Vardenafil improved erectile function in men with ED and improved the sexual quality of life of the couple.

Double-Blind Method↗