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Evaluation of the Effect on Sexual Performance of a Nutraceutical Combination Containing Alpha Lipoic Acid, Vitis vinifera L. and Ginkgo biloba, Compared to Placebo, Avanafil or a Combination of Nutraceutical Plus Avanafil in Males With Type 2 Diabetes M To evaluate if therapy with a nutraceutical combination of alpha lipoic acid, Vitis vinifera L. and Ginkgo biloba (Blunorm forte) can be helpful and be synergic with Avanafil. The trial included 123 males with type 2 diabetic mellitus and with erectile dysfunction (ED), aged ≥18 years. Patients were divided in four different arms: 1 arm: placebo during the three months of treatment and before sexual act; 2 arm: placebo for three months and Avanafil: 1 tablet, 200 mg, 15-30 minutes before sexual act; 3 arm: Blunorm forte: 1 tablet, 40
Erectile dysfunction: avanafil Erectile dysfunction: avanafil Evidence summary Published: 12 August 2014 www.nice.org.uk/guidance/esnm45 pathwaysKey points from the evidence Key points from the evidence The content of this evidence summary was up-to-date in August 2014. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Summary Summary Three randomised controlled trials (RCTs; total n=1334) have evaluated the phosphodiesterase type 5 (PDE5) inhibitor, avanafil, in men with erectile dysfunction in the general population (Goldstein et al. 2012a), with diabetes mellitus (Goldstein et al. 2012b), and post-prostatectomy (Mulhall et al. 2013). Overall, compared with placebo, they found that avanafil 50 mg, 100 mg
Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction: A randomized, double blind, multicenter clinical trial. To compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction. It was a prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, non -inferiority clinical study carried out in patients with erectile dysfunction for at least 3 months and International Index of Erectile Function - Erectile Function domain score of <26 at enrolment. A total of 220 patients were randomized to receive either avanafil tablets 100 mg or sildenafil tablets 50 mg in 1:1 ratio. After 4 weeks of treatment, 40.0% of patients in the avanafil group and 45.6
Efficacy and Safety of Avanafil in Chinese Subjects With Erectile Dysfunction: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial. The incidence of erectile dysfunction (ED) increases with age in mainland China and phosphodiesterase 5 inhibitors (PDE5i) are the major drugs used for its treatment. To determine the efficacy and safety of Chinese developed avanafil as therapy for ED in China. This phase III trial was carried out in 7 medical centers in China. Eligible subjects suffering from ED were allocated randomly into 3 groups (ratio 1:1:1) and orally received a placebo, 100 or 200 mg avanafil for a total of 12 weeks. The primary endpoint was changes in erectile function (EF) domain scores according to the International Index of EF (IIEF
Evaluation of daily avanafil efficacy in improving the endothelial function in Egyptian males with erectile dysfunction. Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor. However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the endothelial markers' serum level and erectile function in patients with erectile dysfunction. In this work, we randomly divided 140 males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction like diabetes mellitus, hypertension and dyslipidaemia into two equal groups: treatment group, treated with 50mg daily oral avanafil, and control group, treated with placebo. The International Index
A Bioequivalence Study of Avanafil in Healthy Chinese Male Subjects Under Fasting and Fed Conditions: Results of a Randomized, Open-Label, Single-Dose, 2-Sequence, 2-Period Crossover Study. This bioequivalence study was conducted to determine the pharmacokinetics and safety profiles of an originator and a generic avanafil formulation in Chinese male subjects under fed and fasting conditions . Each eligible subject was initially randomly given avanafil (200 mg) in a test-reference or reference-test order, before being switched to another study drug sequence after 7 drug-free days. The bioequivalence of test and reference avanafil were determined if the 90%CIs of the geometric mean ratio (GMR) for the area under plasma concentration-time curve (AUC) from time 0 to infinity (AUC ), AUC from
Efficacy and safety of avanafil 200 mg versus sildenafil 100 mg in the treatment of erectile dysfunction after robot-assisted unilateral nerve-sparing prostatectomy: A prospective multicentre study. Phosphodiesterase type 5 inhibitors represent the standard treatment of erectile dysfunction after nerve-sparing prostatectomy. Avanafil is a second-generation phosphodiesterase type 5 inhibitor with a high selectivity for phosphodiesterase type 5 isoform. To date, there are no studies comparing the outcomes of avanafil versus sildenafil in this scenario. In this study, we evaluated the efficacy and safety of avanafil versus sildenafil as a drug for post-prostatectomy rehabilitation. Overall, 160 patients submitted to robot-assisted nerve-sparing prostatectomy for localized prostate cancer at three
Stendra (avanafil) Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links * * * U.S. Food & Drug Administration * Follow FDA * En EspañolSearch FDA * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco ProductsDrug Approval Package * * * * FDA Home * Drugs * Drug Approvals and Databases * Drugs@FDA-STENDRA (avanafil) TabletsCompany: VIVUS, Inc.Application No.: 202276Approval Date: 4/27/2012Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. * Approval Letter(s) (PDF) * Printed Labeling (PDF) * Summary Review (PDF
Development of Validated and Stability-Indicating LC-DAD and LC-MS/MS Methods for Determination of Avanafil in Pharmaceutical Preparations and Identification of a Novel Degradation Product by LCMS-IT-TOF Avanafil (AVA), one of the most effective drugs prescribed for erectile dysfunction, is a pyrimidine-derivative PDE5 inhibitor. In the current work, new LC methods were developed and validated for quantitative determination of avanafil and qualitative determination of its degradation products. The quantitative determination of avanafil was carried out using liquid chromatography with photodiode array detection (LC-DAD) and liquid chromatography-tandem mass spectrometry LC-MS/MS methods, and fully validated according to the ICH Q2 (R1) guideline, while qualitative determination was performed using
Effects of the Phosphodiesterase-5 (PDE-5) Inhibitors, Avanafil and Zaprinast, on Bone Remodeling and Oxidative Damage in a Rat Model of Glucocorticoid-Induced Osteoporosis
EDEUS, a Real-Life Study on the Users of Phosphodiesterase Type 5 Inhibitors: Prevalence, Perceptions, and Health Care-Seeking Behavior Among European Men With a Focus on 2nd-Generation Avanafil Erectile dysfunction (ED) is a multidimensional disorder with an estimated prevalence of 1% to 10% in men younger than 40 years and up to 100% in men in their 70s and 80s. To evaluate the real-life performers, with more self-reported comorbidities; patients used a higher PDE5i dosage and purchased it from official pharmacies more often than performers did. Of avanafil users (n = 39), no differences in total IIEF or subdomain scores were observed after adjusting for confounders. However, avanafil users less often declared its use without an ED diagnosis and a physician prescription. Overall
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction A multi-center, randomized, double-blind, placebo-controlled study was conducted with 158 subjects who were randomized to placebo or avanafil 50, 100, and 200 mg on demand for 8 weeks to evaluate the safety , tolerability, and efficacy of avanafil in the treatment of erectile dysfunction (ED) in Korean men. The primary outcome was the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcomes included changes in the scores of IIEF questions 3 and 4 (IIEF Q3, Q4) from baseline, changes in all domain scores in the IIEF from baseline, Sexual Encounter
Efficacy of Avanafil Fifteen Minutes After Dosing in Men With Erectile Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Study. We examined the therapeutic effects of avanafil 15 minutes after dosing in men with mild to severe erectile dysfunction. This randomized, double-blind, placebo controlled, 12-week study (4-week run-in and 8-week treatment) randomized 145 men to placebo, 147 to avanafil 100 mg and 148 to avanafil 200 mg on demand. The primary efficacy variable was the per subject proportion of sexual attempts during the treatment period in which subjects achieved erection sufficient for vaginal penetration within approximately 15 minutes after dosing as measured by a stopwatch. The attempt had to enable successful completion of sexual intercourse according to SEP question 3
Avanafil: A Review of Its Use in Patients with Erectile Dysfunction. Avanafil (STENDRA™, SPEDRA™, Zepeeed™) is an oral phosphodiesterase type 5 inhibitor indicated for the treatment of erectile dysfunction. Avanafil is rapidly absorbed after oral administration, with a median time to maximum plasma concentration of 30 to 45 min. In a 12-week, randomized, double-blind, placebo-controlled , multicentre trial in patients with erectile dysfunction, avanafil 50, 100 and 200 mg recipients had significantly greater improvements from baseline than placebo recipients in mean international index of erectile dysfunction-erectile function domain scores and in successful vaginal penetration and sexual intercourse attempts (coprimary endpoints). Treatment effects were significantly larger in avanafil 100
An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. This was a 52-week , open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; '100/200-mg' group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3