LEVITRA NEWS HIGHLIGHTS Media Articles Related to Levitra (Vardenafil)
Brief Amnesia After Taking Levitra?
Source: MedicineNet tadalafil Specialty [2008.06.02]
Title: Brief Amnesia After Taking Levitra?
Category: Health News
Created: 6/2/2008
Last Editorial Review: 6/2/2008
Tadalafil (Cialis) In The Treatment Of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2009.05.30]
UroToday.com - This updated review of tadalafil (Cialis), one of the three available phosphodiesterase type 5 (PDE5) inhibitors that revolutionized the treatment of erectile dysfunction (ED), analyzes its latest clinical studies. Tadalafil's most unique and identifying characteristic is its long half-life of 17.5 hours, compared with 4 hours for sildenafil (Viagra) and vardenafil (Levitra).
For Erectile Dysfunction, Physicians Indicate That Opportunity Exists For Emerging Therapies With Improved Efficacy
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2009.04.16]
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that although surveyed primary care physicians (PCPs) are generally satisfied with the efficacy of available phosphodiesterase type 5 (PDE5) inhibitors such as Pfizer's Viagra, Eli Lilly's Cialis and Bayer Healthcare/Schering-Plough/GlaxoSmithKline's Levitra, they are less satisfied with the efficacy of this drug class in difficult-to-treat patient subpopulations.
Published Studies Related to Levitra (Vardenafil)
Does on-demand vardenafil improve erectile function recovery after radical prostatectomy? [2009.01]
The randomized, placebo-controlled trial reported by Montorsi and colleagues attempted to determine if nightly vardenafil [generic for Levitra] was more effective than on-demand drug in restoring erectile function after radical prostatectomy. No significant difference in outcomes was found between the study groups at 11 or 13 months after surgery... The authors' conclusion that the data support a shift towards on-demand phosphodiesterase 5 inhibitor use after radical prostatectomy is not supported by the data.
Effect of vardenafil on blood pressure profile of patients with erectile dysfunction concomitantly treated with doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia. [2008.09]
PURPOSE: We investigated the effect of the combination of the doxazosin gastrointestinal therapeutic system and 10 mg vardenafil [generic for Levitra] on the hemodynamic status of patients with benign prostatic hyperplasia and erectile dysfunction... CONCLUSIONS: In patients on the doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia a single 10 mg dose of vardenafil had no symptomatic hemodynamic effects.
Effect of Vardenafil on Blood Pressure Profile of Patients With Erectile Dysfunction Concomitantly Treated With Doxazosin Gastrointestinal Therapeutic System for Benign Prostatic Hyperplasia. [2008.07.16]
PURPOSE: We investigated the effect of the combination of the doxazosin gastrointestinal therapeutic system and 10 mg vardenafil [generic for Levitra] on the hemodynamic status of patients with benign prostatic hyperplasia and erectile dysfunction... CONCLUSIONS: In patients on the doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia a single 10 mg dose of vardenafil had no symptomatic hemodynamic effects.
A double-blind, placebo-controlled, randomized clinical study of the effects of vardenafil on human nasal patency. [2008.05]
BACKGROUND: Vardenafil [generic for Levitra], a selective phosphodiesterase 5 (PDE5) inhibitor, may affect nasal patency because of its adverse-effect profile. This double-blind, placebo-controlled, randomized clinical study sought to assess the effect of vardenafil on nasal patency in patients at a university hospital... CONCLUSION: Objective and subjective nasal obstruction after administration of vardenafil was significantly higher in this study than in previously reported studies. The effect of congestion can be reversed by local decongestants. The role of PDE5 inhibitors in nasal physiology merits additional investigation.
Vardenafil improves ejaculation success rates and self-confidence in men with erectile dysfunction due to spinal cord injury. [2008.04.01]
STUDY DESIGN: Multicenter, double-blind, placebo-controlled, parallel-group study. OBJECTIVE: To assess the effect of the oral phosphodiesterase type-5 inhibitor, vardenafil [generic for Levitra], on ejaculation rates and self-confidence in men with spinal cord injury (SCI). SUMMARY OF BACKGROUND DATA: Spinal command of male sexual functions is often seriously impaired by traumatic spinal cord injury (SCI). A high proportion of men with SCI cannot ejaculate during sexual intercourse. SCI-related ejaculatory disorders are often responsible for male infertility. Sexual dysfunction associated with SCI can also affect men's self-confidence... CONCLUSION: Vardenafil significantly improved ejaculation and self-confidence in men with erectile dysfunction due to SCI.
Clinical Trials Related to Levitra (Vardenafil)
ELATED: Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction [Completed]
This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2
factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in
males with erectile dysfunction.
The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking
ED medication. For ED treatment-naïve subjects (ie, previously not treated with ED
medication), the unmedicated period can be only 2 weeks.
Approximately 150 investigational centres may be utilised with approximately 10 subjects
screened and entered into a 4 week treatment free period at Visit 1 to subsequently enroll
approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites should
try to recruit approximately 50% of subjects who have not previously tried oral PDE5
inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects
whose partners are interested in being involved.
Sites will be randomized in a 1: 1:1: 1 ratio to receive either the education intervention at
the Primary care Physician (PCP) level, at the subject level, both levels or no intervention
(usual care).
The PCP education program is an accredited CME program and included a comprehensive overview
on the screening and diagnosis of ED, the available treatment options and appropriate
treatment selection, as well as subject and partner counseling. The subject education was a
two-pronged approach which included physician-to-subject instruction and a direct-to-subject
education method.
After the unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4
weeks. This will be followed by a flexible dose titration period of 4 weeks during which
subjects may maintain the previous dosage regimen or will step up to 20 mg of vardenafil or
will step down to 5 mg vardenafil. There is a final 4 week treatment period where the
previous dosage regimen is either maintained, increased or decreased by one step according to
the three applicable dosage strengths of vardenafil (5, 10 or 20 mg). The highest applicable
dosage regimen of 20 mg vardenafil will not be exceeded. A 24 hour follow-up phone call is
required within 24 hours of the last dose of vardenafil to collect data concerning serious
adverse events, if needed.
REALISE Levitra® - Real Life Safety and Efficacy of Levitra [Completed]
Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily
life conditions in a large number of subjects with erectile dysfunction (ED)
A Double-Blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction [Completed]
To find out more information on how treating impotence with vardenafil in comparison to
placebo affects the quality of life (QoL) of men and their partners. Subjects will receive
10mg vardenafil or placebo for 4 weeks followed by an 8 week period when the dose of
vardenafil may be reduced to 5mg or increased to 20mg. Subjects will then receive their
'preferred' dose for 14 weeks. During this time Quality of Life Measures will be collected
via questionnaires
Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-Sparing Prostatectomy for Improving ED [Active, not recruiting]
To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction [Completed]
A total of 173 subjects were randomized in 6 centers (vardenafil: 129 subjects; placebo: 44
subjects). All 173 randomized subjects were analyzed for safety. Of these, 162 subjects
(94%) were included in the ITT sample (vardenafil: 123 subjects; placebo: 39 subjects) and
149 subjects (86%) were included in the PP sample (vardenafil: 115 subjects; placebo: 34
subjects). The PP sample was only used to analyze the primary efficacy variable (EF domain
score).
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