vardenafil dihydrochloride profile

Vardenafil Dihydrochloride: A piperazine derivative, PHOSPHODIESTERASE 5 INHIBITOR and VASODILATOR AGENT that is used as a UROLOGICAL AGENT in the treatment of ERECTILE DYSFUNCTION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	135414253
CHEMBL ID	2106480
SCHEMBL ID	5685
MeSH ID	M0387384

Synonym
vardenafil dihydrochloride
piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-, dihydrochloride
2-(2-ethoxy-5-(4-ethylpiperazin-1-yl-1-sulfonyl)phenyl)-5-methyl-7-propyl-3h-imidazo(5,1-f)(1,2,4)triazin-4-one dihydrochloride
vardenafil dihydrochloride [usan]
224789-15-5
vardenafil dihydrochoride (usan)
D02731
unii-5o8r96xmh7
5o8r96xmh7 ,
nsc 759103
nsc-759103
piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, dihydrochloride
imidazo[5,1-f][1,2,4]triazin-4(1h)-one, 2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-, hydrochloride (1:2)
vardenafil dihydrochloride [mart.]
vardenafil dihydrochloride [who-dd]
CHEMBL2106480
vardenafil dihydrochloride salt
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h -imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f](1,2,4]triazine-4-one dihydrochioride
2-[2-ethoxy-5-(4ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride
NOIHTGOGFDFCBN-UHFFFAOYSA-N
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochioride
SCHEMBL5685
5-amino-2-fluorobenzylalcohol
1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-piperazine dihydrochloride
imidazo[5,1-f][1,2,4]triazin-4(1h)-one, 2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-, hydrochloride (1:2); piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-eth
vardenafil dihydrochloride 1.0 mg/ml in methanol (as free base)
J-014734
2-(2-ethoxy-5-(4-ethylpiperazin-1-ylsulfonyl)phenyl)-5-methyl-7-propylimidazo[1,5-f][1,2,4]triazin-4(3h)-one dihydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazin-4-one;dihydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1h-imidazo[5,1-f][1,2,4]triazin-4-one;dihydrochloride
F14825
AS-14122
Q27262637
2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3h)-one dihydrochloride
1ST8580
vardenafil dihydrochloride 100 microg/ml in acetonitrile
ZIA78590
1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-piperazine;levitra
A925520
CS-0103193
HY-B0442C

Excerpt	Reference
" - The development of the PDE-5 inhibitors vardenafil and tadalafil prompts the question of whether and how these three substances differ in terms of their efficacy and adverse effects."	( Erectile dysfunction: comparison of efficacy and side effects of the PDE-5 inhibitors sildenafil, vardenafil and tadalafil--review of the literature. Gleiter, CH; Gresser, U, 2002)
" Few adverse events were observed."	( Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. Brock, G; Gleave, M; Karlin, GS; Lipshultz, LI; Nehra, A; Padma-Nathan, H; Seger, M, 2003)
" The most common adverse events, flushing and headache, were generally mild and transient."	( The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men. Bandel, TJ; Buvat, J; Hatzichristou, D; Laferriere, N; Montorsi, F; Porst, H, 2004)
" Reported adverse event rates were 35."	( Safety and efficacy of vardenafil in patients with erectile dysfunction: result of a bridging study in Japan. Ishii, N; Kamidono, S; Nagao, K; Osada, T, 2004)
" Adverse reactions are generally transient and mild to moderate in nature."	( [Efficacy and safety of vardenafil for men with erectile dysfunction]. Jiang, H; Zhu, J, 2004)
" International and domestic clinical studies showed it to be safe and effective in treating ED with mild temporary side effects such as headache, dizziness, flushing and rhinitis."	( [Cardiovascular safety of vardenafil]. Xin, Z, 2004)
" Vardenafil was generally safe and well tolerated."	( [Efficacy and safety of vardenafil in men with erectile dysfunction and depression]. Hu, L, 2004)
" The incidence of adverse events was higher for vardenafil than for placebo."	( [Efficacy and safety of oral vardenafil in the treatment of erectile dysfunction]. Hong, K; Ma, H; Pan, T; Tang, W; Zhuang, S, 2004)
"Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies."	( [Efficacy and safety of oral vardenafil in the treatment of erectile dysfunction]. Hong, K; Ma, H; Pan, T; Tang, W; Zhuang, S, 2004)
" All adverse events were recorded and reported."	( [Efficacy and safety of vardenafil in patients with erectile dysfunction. Results of the Mexican Multicentric Study]. Barreto-Fernández, MA; Feria-Bernal, G; Hurtado-Coll, A; Jaspersen-Gastelum, J; Mendoza-Valdés, A; Olguin, J; Pacheco-Gahbler, C; Pérez-García, J; Quinzaños-Sordo, LF; Rubio-Aurioles, E; Sentíes-Hernández, IR; Sotomayor-de-Zavaleta, M; Tapia-Serrano, Mdel R; Telich-Vidal, M; Ugarte-y-Romano, F; Ureta-Sánchez, SE, )
" Adverse events were mild to moderate and the most common were headache, dyspepsia, rhinitis and facial flushing."	( [Efficacy and safety of vardenafil in patients with erectile dysfunction. Results of the Mexican Multicentric Study]. Barreto-Fernández, MA; Feria-Bernal, G; Hurtado-Coll, A; Jaspersen-Gastelum, J; Mendoza-Valdés, A; Olguin, J; Pacheco-Gahbler, C; Pérez-García, J; Quinzaños-Sordo, LF; Rubio-Aurioles, E; Sentíes-Hernández, IR; Sotomayor-de-Zavaleta, M; Tapia-Serrano, Mdel R; Telich-Vidal, M; Ugarte-y-Romano, F; Ureta-Sánchez, SE, )
" There was a low rate of discontinuations due to adverse events and a favorable safety profile."	( [Efficacy and safety of vardenafil in patients with erectile dysfunction. Results of the Mexican Multicentric Study]. Barreto-Fernández, MA; Feria-Bernal, G; Hurtado-Coll, A; Jaspersen-Gastelum, J; Mendoza-Valdés, A; Olguin, J; Pacheco-Gahbler, C; Pérez-García, J; Quinzaños-Sordo, LF; Rubio-Aurioles, E; Sentíes-Hernández, IR; Sotomayor-de-Zavaleta, M; Tapia-Serrano, Mdel R; Telich-Vidal, M; Ugarte-y-Romano, F; Ureta-Sánchez, SE, )
" Adverse drug reactions were very rare (1."	( The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study--results from 29 358 German patients. Landen, H; Stauch, K; van Ahlen, H; Zumbé, J, )
" Adverse events were monitored throughout the study."	( Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study. Edmunds, K; Moncada, I; Montorsi, F; Porst, H; Stancil, BN; Valiquette, L; Vézina, JG; Young, JM, 2005)
" Vardenafil was generally well tolerated; most adverse events were mild to moderate, with headache and flushing reported most frequently."	( Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study. Edmunds, K; Moncada, I; Montorsi, F; Porst, H; Stancil, BN; Valiquette, L; Vézina, JG; Young, JM, 2005)
" Those safe and effective agents were originally developed for their cardiovascular effects and were incidentally found to enhance erections."	( Cardiac safety in clinical trials of phosphodiesterase 5 inhibitors. Carson, CC, 2005)
" The most commonly reported treatment-emerging adverse events were headache (3."	( Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients with erectile dysfunction and arterial hypertension treated with multiple antihypertensives. Kupper, W; Neureither, M; Reblin, T; van Ahlen, H; Wahle, K; Yassin, A, 2005)
" The most frequently reported drug-related adverse events were headache (vardenafil 15%, placebo 4%), flushing (vardenafil 6%, placebo 0%), nasal congestion (vardenafil 5%, placebo 0%), and dyspepsia (vardenafil 4%, placebo 0%)."	( Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Colopy, MW; Finkbeiner, AE; Giuliano, F; Kennelly, M; Kim, ED; Montorsi, F; Pommerville, PJ; Rubio-Aurioles, E; Wachs, BH; Wilkins, HJ, 2006)
" Several large-scale studies indicated vardenafil was effective and safe in the treatment of these difficult-to-treat ED patients, including ED with depression or diabetes, ED after radical retropubic prostatectomy, ED caused by spinal cord injury, and sildenafil nonresponders."	( [Efficacy and safety of vardenafil in difficult-to-treat erectile dysfunction men]. Wang, CH, 2006)
" The most commonly reported treatment-emergent adverse events were headache (3."	( Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction. Merfort, F; Neureither, M; Reblin, T; Van Ahlen, H; Yassin, A; Ziegler, D, 2006)
" Safety was assessed by adverse events (AEs)."	( Real-life safety and efficacy of vardenafil in the treatment of erectile dysfunction-results from 30,010 U.S. patients. Cheng, E, 2007)
" Because doctors worry about the severe adverse events of drug combination, they tend to be reluctant to prescribe ED medicines for patients."	( [Efficacy and safety of vardenafil in the treatment of erectile dysfunction in men with hypertension]. Li, HJ, 2006)
" A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3."	( Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care. Cho, B; Kim, CH; Kim, CM; Kim, DH; Kim, YS; Lee, SY; Rho, M; Shin, HC; Sunwoo, S; Yang, YJ, )
" All adverse events were recorded and assessed for a possible relationship to treatment, and for severity."	( The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study of 2824 patients from the Middle East. Al Mitwally, K; Fouad, W; Kamel, A; Khaouli, R; Landen, H; Sabha, M, 2007)
" The rate of adverse drug reactions (ADRs) was low (9."	( The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study of 2824 patients from the Middle East. Al Mitwally, K; Fouad, W; Kamel, A; Khaouli, R; Landen, H; Sabha, M, 2007)
" Safety assessments included laboratory tests, vital signs, 12-lead electrocardiogram recordings, and patients' reporting of adverse events."	( The efficacy and safety of vardenafil in East Asian men with erectile dysfunction. Chen, KK; Ishii, N; Paick, JS, 2007)
" The most frequent adverse events were vasodilatation (primarily facial flushing), rhinitis, and headache, all of which were of mild intensity."	( The efficacy and safety of vardenafil in East Asian men with erectile dysfunction. Chen, KK; Ishii, N; Paick, JS, 2007)
" Adverse effects were observed in 4 patients: headache in 2, palpitation and flush in 1, and dyspepsia in the other."	( [Efficacy and safety of vardenafil for kidney transplant recipients with erectile dysfunction]. Ju, W; Xiao, CG; Xiao, YJ; Yang, J; Zeng, FQ; Zhang, XP, 2008)
"Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for kidney transplant recipients with ED."	( [Efficacy and safety of vardenafil for kidney transplant recipients with erectile dysfunction]. Ju, W; Xiao, CG; Xiao, YJ; Yang, J; Zeng, FQ; Zhang, XP, 2008)
" The incidence and type of treatment-related adverse events with vardenafil 10 mg ODT were comparable with those of the film-coated tablet formulation."	( The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. Beneke, M; Boermans, A; Debruyne, F; Ewald, S; Sperling, H; Ulbrich, E, 2010)
" No serious adverse reactions were observed."	( The efficacy and safety of testosterone undecanoate (Nebido(®)) in testosterone deficiency syndrome in Korean: a multicenter prospective study. Ahn, TY; Kim, JJ; Kim, SW; Lee, JY; Lee, SW; Moon, DG; Paick, JS; Park, JK; Park, K; Park, MG; Park, NC; Seo, JT; Yang, DY, 2010)
" Treatment-emergent adverse events were mostly mild to moderate in severity, and comparable in both incidence and type with those of the film-coated tablet formulation."	( The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. Beneke, M; Ewald, S; Gittelman, M; McMahon, CG; Rodríguez-Rivera, JA; Ulbrich, E, 2010)
" The incidence of adverse events was low, and 97."	( The Real-Life Safety and Efficacy of vardenafil (REALISE) study: results in men from Europe and overseas with erectile dysfunction and cardiovascular or metabolic conditions. Hanisch, JU; Stauch, K; Van Ahlen, H; Zumbé, J, 2010)
" Adverse events (AEs) were mostly mild to moderate in severity, occurring with higher incidence in the vardenafil vs."	( Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. Ewald, S; Gittelman, M; Norenberg, C; Sperling, H; Ulbrich, E, 2011)
" Adverse events (AEs) were recorded throughout the study."	( Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. Beneke, M; Gleissner, J; Hermanns, M; Merfort, F; Schneider, T; Ulbrich, E, 2011)
" Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and effective."	( 10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. Costabile, RA; Lowe, G, 2012)
"Summarized reports of adverse events (AEs) for each PDE5-i were requested from the Center for Drug Evaluation and Research within the FDA."	( 10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. Costabile, RA; Lowe, G, 2012)
" 10-year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors."	( 10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. Costabile, RA; Lowe, G, 2012)
"We conducted a questionnaire investigation among 891 ED patients treated by on-demand use of oral vardenafil at 20 mg every 3 days from March 2007 to January 2010, covering the general information of the patients, their need for and attitudes towards the treatment, clinical efficacy and adverse events of the drug, and satisfaction of the patients and their partners after 12 weeks of treatment."	( [Efficacy and safety of vardenafil in the treatment of erectile dysfunction: a report of 700 cases]. Fang, JJ; Zhong, DC; Zhu, XW, 2011)
" Most frequent adverse events included flushing (15%), dizziness and headache (10%), dyspepsia (3%), and nasal congestion (1%)."	( [Efficacy and safety of vardenafil in the treatment of erectile dysfunction: a report of 700 cases]. Fang, JJ; Zhong, DC; Zhu, XW, 2011)
" No patient reported any serious (grade ≥ 2) adverse event (AE)."	( A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Carini, M; Gacci, M; Lapini, A; Maggi, M; Rossetti, MA; Serni, S; Siena, G; Tosi, N; Vignozzi, L; Vittori, G, 2012)
"A low incidence of some PDE-related adverse events may be reflected by the high selectivity of avanafil against non-PDE5 isozymes."	( Selectivity of avanafil, a PDE5 inhibitor for the treatment of erectile dysfunction: implications for clinical safety and improved tolerability. Burnett, AL; Day, WW; DiDonato, K; Heller, WH; Kikkawa, K; Kotera, J; Omori, K; Peterson, CA; Wang, R; Yee, S, 2012)
" Lower selectivity against PDE1, PDE6, and PDE11 is consistent with results from randomized, placebo-controlled, phase 3 trials in which musculoskeletal and hemodynamic adverse events were reported in <2% of patients and no color vision-related abnormalities were reported with avanafil doses up to 200 mg once daily."	( Selectivity of avanafil, a PDE5 inhibitor for the treatment of erectile dysfunction: implications for clinical safety and improved tolerability. Burnett, AL; Day, WW; DiDonato, K; Heller, WH; Kikkawa, K; Kotera, J; Omori, K; Peterson, CA; Wang, R; Yee, S, 2012)
"Data suggest that avanafil may confer a safety benefit, in terms of a lower incidence of specific adverse events, by virtue of its high specificity to PDE5 and its overall selectivity against other PDE isozymes."	( Selectivity of avanafil, a PDE5 inhibitor for the treatment of erectile dysfunction: implications for clinical safety and improved tolerability. Burnett, AL; Day, WW; DiDonato, K; Heller, WH; Kikkawa, K; Kotera, J; Omori, K; Peterson, CA; Wang, R; Yee, S, 2012)
" PDE5-Is are generally safe and well tolerated, and there is no major difference on the safety profile."	( Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Chen, Q; Ding, H; Lee, J; Liu, Y; Mao, C; Qin, X; Ren, Z; Tang, J; Tian, J; Yang, Z; Yuan, J; Zhang, R, 2013)
" This pilot study of 10 patients suggests that vardenafil use is safe in patients before CABG surgery."	( The safety of preoperative vardenafil in patients undergoing coronary artery bypass graft surgery. Ali, A; Binder, A; Jovin, IS; Katlaps, G; Martin, L; Mohmand, A; Pipkin, M; Stewart, H; Szentpetery, S, 2013)
" Vardenafil was well tolerated and adverse events were consistent with the known safety profile of phosphodiesterase type 5 inhibitors."	( The real-life perception of efficacy, attitude, satisfaction and safety of vardenafil therapy (REPEAT): a prospective, non-interventional, observational study. Hanisch, JU; Hartmann, U; Mattern, A, 2014)
" Specific adverse events with PDE5 inhibitors included headache (12."	( Efficacy and safety of phosphodiesterase type 5 (PDE5) inhibitors in treating erectile dysfunction after bilateral nerve-sparing radical prostatectomy. Cui, Y; Gao, Z; Liu, X; Shi, L, 2016)
" These products represent a major safety threat for the consumers in Egypt and the Middle East, especially; the target audience is mostly affected with heart and blood pressure problems seeking natural and safe alternatives to the well-established Phosphodiesterase 5 Inhibitors (PDE-5Is)."	( Male enhancement Nutraceuticals in the Middle East market: Claim, pharmaceutical quality and safety assessments. ElAgouri, G; ElAmrawy, F; ElYazbi, A; Eshra, A; Nounou, MI, 2015)
" While other ocular examinations did not reveal any differences in general some mild to moderate but no serious adverse events have been reported."	( Ocular side effects of Levitra Mazinani, BA; Roessler, G; Vobig, M; Walter, P, 2019)

Excerpt	Reference
"The pharmacodynamic effect on penile rigidity and tumescence and the pharmacokinetic properties of single oral doses of 10 and 20 mg vardenafil, a new PDE5-inhibitor, were investigated in 21 erectile dysfunction patients."	( Vardenafil increases penile rigidity and tumescence in erectile dysfunction patients: a RigiScan and pharmacokinetic study. Engelmann, R; Heidrich, A; Horstmann, R; Jockenhövel, F; Klotz, T; Rohde, G; Sachse, R; Wensing, G, 2001)
" When administered after an overnight fast and after a high-fat breakfast, vardenafil geometric mean Cmax was 17."	( Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. Dawkins, R; Mazzu, A; Rajagopalan, P; Sundaresan, P; Xia, C, 2003)
"1 mg/kg vardenafil is limited by its pharmacokinetic properties (Tmax=1 h; T1/2=1."	( Vardenafil preclinical trial data: potency, pharmacodynamics, pharmacokinetics, and adverse events. Bischoff, E, 2004)
" This review comparatively discusses the major characteristics of the pharmacokinetic profile of all 3 PDE5 inhibitors, including bioavailability and rate of absorption, Biopharmaceutical Classification System categorization, elimination mechanisms, and metabolic profile including active metabolites, as well as the drug-drug interaction potential and modification of pharmacokinetic properties under selected physiologic and pathophysiologic conditions."	( The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. Gupta, M; Kovar, A; Meibohm, B, 2005)
"To investigate the pharmacodynamic effects of the combined administration of vardenafil and ethanol on blood pressure and heart rate and to study the mutual pharmacokinetic interaction, safety and tolerability of the combination."	( Simultaneous administration of vardenafil and alcohol does not result in a pharmacodynamic or pharmacokinetic interaction in healthy male subjects. Bauer, R; Heinig, R; Rohde, G; Unger, S; Wensing, G, 2006)
" No clinically relevant pharmacodynamic or pharmacokinetic interactions were detected."	( Simultaneous administration of vardenafil and alcohol does not result in a pharmacodynamic or pharmacokinetic interaction in healthy male subjects. Bauer, R; Heinig, R; Rohde, G; Unger, S; Wensing, G, 2006)
" This method was successfully applied to a pharmacokinetic study after oral administration of vardenafil 20mg tablet in Korean healthy male volunteers."	( Liquid chromatography/tandem mass spectrometry method for the simultaneous determination of vardenafil and its major metabolite, N-desethylvardenafil, in human plasma: application to a pharmacokinetic study. Bae, SK; Ku, HY; Liu, KH; Shin, JG; Shon, JH, 2009)
" The high sensitivity and acceptable performance of the assay allowed its application to the analysis of plasma samples obtained following the oral administration of vardenafil to healthy male volunteers in a pharmacokinetic study."	( Validated LC-MS/MS assay for the quantitative determination of vardenafil in human plasma and its application to a pharmacokinetic study. Addison, RS; Altman, PM; Lake, ST; Vaisman, J, 2010)
"Three clinical trials were conducted: (i) a randomized 4-fold crossover study to assess the effect of food and water on the pharmacokinetics of vardenafil ODT, compared with vardenafil FCT, in healthy men; (ii) a phase I study to assess single and multiple doses of vardenafil ODT, compared with a single dose of vardenafil FCT, in young and elderly men with ED; and (iii) a pharmacokinetic substudy of a phase III trial in men of broad age range with ED."	( Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Böttcher, MF; Dietrich, H; Heinig, R; Weimann, B, 2011)
"Vardenafil ODT was rapidly absorbed after oral administration without water, with a similar pharmacokinetic profile to vardenafil FCT, except that the ODT exhibited significantly greater bioavailability."	( Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Böttcher, MF; Dietrich, H; Heinig, R; Weimann, B, 2011)
" Vardenafil ODT is a convenient formulation, with pharmacokinetic and safety characteristics that are appropriate for the treatment of ED."	( Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Böttcher, MF; Dietrich, H; Heinig, R; Weimann, B, 2011)
"To evaluate the pharmacokinetic parameters of a single oral dose of vardenafil in patients with pulmonary hypertension (PH)."	( High inter-individual variability of vardenafil pharmacokinetics in patients with pulmonary hypertension. Bondesson, UG; Egeröd, HC; Hedeland, M; Henrohn, D; Sandqvist, AM; Schneede, J; Wikström, BG, 2013)
" Pharmacokinetic parameters were calculated using model-independent analysis."	( High inter-individual variability of vardenafil pharmacokinetics in patients with pulmonary hypertension. Bondesson, UG; Egeröd, HC; Hedeland, M; Henrohn, D; Sandqvist, AM; Schneede, J; Wikström, BG, 2013)
"The pharmacokinetic profile of vardenafil overall revealed considerable inter-individual variability in patients with PH."	( High inter-individual variability of vardenafil pharmacokinetics in patients with pulmonary hypertension. Bondesson, UG; Egeröd, HC; Hedeland, M; Henrohn, D; Sandqvist, AM; Schneede, J; Wikström, BG, 2013)
" Dose-ranging study was performed in two subjects to determine the appropriate inhalational dose, followed by an open, randomized, crossover, single dose pharmacokinetic study in 12 subjects, which compared a single 10-mg oral dose to the inhalation dose."	( Comparison of Pharmacokinetics of Vardenafil Administered Using an Ultrasonic Nebulizer for Inhalation vs a Single 10-mg Oral Tablet. Altman, P; Berry, B; Rowe, J; Vaisman, J, 2016)
" A single dose clinical pharmacokinetic study was carried out for the selected formulation."	( Development and single dose clinical pharmacokinetics investigation of novel zein assisted- alpha lipoic acid nanoencapsulation of vardenafil. Ahmed, OAA, 2018)
" Pharmacokinetic parameters following each treatment were compared and adverse events assessed."	( Pharmacokinetics comparison of vardenafil as administered by an intranasal spray formulation vs a 10-mg oral tablet. Chow, MSS; Chow, SL; Dong, F; Louie, SG; Paik, A; Sathananthan, A; Wang, J; White, S, 2023)
" The variability of the pharmacokinetic parameters was also less with intranasal than oral administration."	( Pharmacokinetics comparison of vardenafil as administered by an intranasal spray formulation vs a 10-mg oral tablet. Chow, MSS; Chow, SL; Dong, F; Louie, SG; Paik, A; Sathananthan, A; Wang, J; White, S, 2023)
" Nevertheless, the changes of pharmacokinetic parameters in the present study are likely a reflection of the differences between intranasal and oral administration of the formulations."	( Pharmacokinetics comparison of vardenafil as administered by an intranasal spray formulation vs a 10-mg oral tablet. Chow, MSS; Chow, SL; Dong, F; Louie, SG; Paik, A; Sathananthan, A; Wang, J; White, S, 2023)

Excerpt	Reference
"Perform a systematic review and meta-analysis of available prospective and cross-sectional studies on the use of PDE5-Is alone or in combination with α1-adrenergic blockers in patients with LUTS/benign prostatic hyperplasia (BPH)."	( A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with α-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Carini, M; Corona, G; Gacci, M; Kaplan, SA; Maggi, M; McVary, KT; Mirone, V; Roehrborn, CG; Salvi, M; Serni, S; Vignozzi, L, 2012)
" In this study, we validated a discriminant analysis using an ultra-compact, portable, and low-cost Raman scattering spectrometer combined with multivariate analysis."	( Detection Method of Falsified Medicines by Using a Low-Cost Raman Scattering Spectrometer Combined with Soft Independent Modeling of Class Analogy and Partial Least Squares Discriminant Analysis. Kimura, K; Sanada, T; Tsuboi, H; Yoshida, N, 2021)

Excerpt	Reference
" Relative bioavailability was slightly higher for the 40-mg dose than for the 20-mg dose."	( Vardenafil increases penile rigidity and tumescence in men with erectile dysfunction after a single oral dose. Hensen, J; Horstmann, R; Liedl, T; Rohde, G; Sachse, R; Schrott, KM; Stark, S; Wensing, G, 2001)
" In humans, vardenafil is rapidly absorbed (Tmax approximately 40 min) and more slowly metabolized (T1/2 approximately 4 h), with an absolute bioavailability of 14."	( Vardenafil preclinical trial data: potency, pharmacodynamics, pharmacokinetics, and adverse events. Bischoff, E, 2004)
" The absolute oral bioavailability is about 15%."	( [Pharmacodynamics and pharmacokinetics of vardenafil in patients with erectile dysfunction]. Guo, Y; Jin, J, 2004)
" This review comparatively discusses the major characteristics of the pharmacokinetic profile of all 3 PDE5 inhibitors, including bioavailability and rate of absorption, Biopharmaceutical Classification System categorization, elimination mechanisms, and metabolic profile including active metabolites, as well as the drug-drug interaction potential and modification of pharmacokinetic properties under selected physiologic and pathophysiologic conditions."	( The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. Gupta, M; Kovar, A; Meibohm, B, 2005)
" This form is effective, safe, and has a higher bioavailability as compared to vardenafil in the form of coated tablets."	( [Levitra (oral dispersible tablet)--an innovative drug for the treatment of patients with erectile dysfunction]. Korneev, IA, )
" VAR is rapidly absorbed and slowly metabolized, with an absolute bioavailability of 15%."	( Vardenafil dihydrochloride. Ashour, AE; Kassem, MG; Rahman, AF, 2014)
" The transdermal bioavailability of VRD from the nanoethosome film was approximately twofold higher than the oral bioavailability from an aqueous suspension."	( Nanoethosomal transdermal delivery of vardenafil for treatment of erectile dysfunction: optimization, characterization, and in vivo evaluation. Fahmy, UA, 2015)
"Delivery of vardenafil (for improvement of erectile function) via the inhaled route of administration may be advantageous in that this avoids extensive first pass metabolism and may therefore increase the bioavailability (hence the reliability of absorption) and shorten the time of pharmacological onset of activity."	( Comparison of Pharmacokinetics of Vardenafil Administered Using an Ultrasonic Nebulizer for Inhalation vs a Single 10-mg Oral Tablet. Altman, P; Berry, B; Rowe, J; Vaisman, J, 2016)
" Vardenafil (VDF) is a relatively new phosphodiesterase-5 inhibitor that exhibits a limited oral bioavailability (≈15%) due to extensive first-pass metabolism."	( Preparation and characterization of intravaginal vardenafil suppositories targeting a complementary treatment to boost in vitro fertilization process. Abu Lila, AS; Ghazy, FS; Gomaa, E; Hasan, AA, 2018)
" VAR has a short elimination half-life (4-5 h) and suffers low oral bioavailability (15%)."	( Polyamidoamine (PAMAM) dendrimers as potential release modulators and oral bioavailability enhancers of vardenafil hydrochloride. Mohamed, MI; Tadros, MI; Tawfik, MA, 2019)
" The oral bioavailability of this formulation is higher than that of the parent drug."	( Lodenafil. Al-Majed, AA; Alshehri, YM; Attwa, MW; Bakheit, AH, 2022)

Excerpt	Reference
" Dosage changes are not warranted based on the wide therapeutic index and the efficacy observed with vardenafil in Phase III studies that were not restricted with respect to food."	( Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. Dawkins, R; Mazzu, A; Rajagopalan, P; Sundaresan, P; Xia, C, 2003)
" The dosage of vardenafil may be reduced to 5 mg (especially in older individuals) to improve tolerance or be increased up to 20 mg (especially in the presence of organic diseases aggravating erectile dysfunction) to improve efficacy."	( [Medication of the month. Vardenafil (Levitra)]. Scheen, AJ, 2003)
" Dose-response relaxation curves to cumulative dosings of vardenafil (1 nM-10 microM) were constructed alone and in the presence of 10 mM L-NAME."	( Pro-erectile effect of vardenafil: in vitro experiments in rabbits and in vivo comparison with sildenafil in rats. Alexandre, L; Bernabe, J; Bischoff, E; Giuliano, F; Haning, H; Niewoehner, U, 2003)
" A placebo-controlled and positive-controlled, period-balanced, double-blinded, 6-way crossover study evaluated therapeutic and supratherapeutic oral doses of vardenafil (10 and 80 mg, respectively) and sildenafil (50 and 400 mg, respectively), therapeutic doses of moxifloxacin (400 mg), and a placebo in 58 healthy men (mean age 53 years), with dosing every 3 days."	( Evaluation of vardenafil and sildenafil on cardiac repolarization. Boyle, DA; Dabiri, GA; Ilson, BE; Montague, TH; Morganroth, J; Patel, BR; Sethuraman, VS; Shaddinger, BC, 2004)
"To determine the efficacy and tolerability of flexible dosing with vardenafil in a broad population of men with erectile dysfunction (ED)."	( Efficacy of vardenafil in men with erectile dysfunction: a flexible-dose community practice study. Beneke, M; Bernard, I; Potempa, AJ; Ulbrich, E, 2004)
"In this community practice setting, vardenafil was shown to be a highly effective and generally well-tolerated treatment for men with ED when dosing was titrated by the physician to individual patient requirements."	( Efficacy of vardenafil in men with erectile dysfunction: a flexible-dose community practice study. Beneke, M; Bernard, I; Potempa, AJ; Ulbrich, E, 2004)
" B-SBP, B-DBP, and HR were recorded before each 50-mg sildenafil dosing and after 30, 60, 120, and 240 minutes."	( Cardiovascular parameter changes in patients with erectile dysfunction using pde-5 inhibitors: a study with sildenafil and vardenafil. Dicuio, M; Dinelli, N; Ghiadoni, L; Mondaini, N; Morelli, G; Pomara, G; Pomara, S; Salvetti, A; Selli, C; Taddei, S; Travaglini, F, )
" The same results were extracted for the two flexible 'as needed' dosing trials."	( Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports. Athanasopoulos, A; Barbalias, G; Gyftopoulos, K; Markou, S; Perimenis, P, 2004)
" Studies showed that clinical dosage of vardenafil could decrease the systematic arterial blood pressure mildly (< 10 mmHg) , however, it did not interact in a potentially hazardous way with antihypertensive or antianginal therapy, with the exception of organic nitrates."	( [Cardiovascular safety of vardenafil]. Xin, Z, 2004)
" So the adjustment of vardenafil dosage is not warranted based on a wide therapeutic index and the efficacy observed with vardenafil in Phase III studies, which need not be restricted with respect to food."	( [Effects of food and alcohol on the pharmacokinetics of vardenafil]. He, ZJ, 2005)
"To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials."	( Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis. Eardley, I; Giuliano, F; Hellstrom, WJ; Homering, M; Montorsi, F; Taylor, T; Valiquette, L, 2005)
" Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12."	( Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis. Eardley, I; Giuliano, F; Hellstrom, WJ; Homering, M; Montorsi, F; Taylor, T; Valiquette, L, 2005)
"In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3)."	( Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis. Eardley, I; Giuliano, F; Hellstrom, WJ; Homering, M; Montorsi, F; Taylor, T; Valiquette, L, 2005)
" The review is aimed at providing comparative clinical pharmacology data to allow for scientifically rational, evidence-based prescribing and dosing decisions regarding the clinical use of these medications for the treatment of erectile dysfunction."	( The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. Gupta, M; Kovar, A; Meibohm, B, 2005)
" The present analysis used data from patient diaries completed daily, which included information concerning attempts at sexual intercourse, time from dosing to attempt, penetration, and maintenance of erection sufficient for successful intercourse."	( Erectile response to vardenafil in men with a history of nonresponse to sildenafil: a time-from-dosing descriptive analysis. Aliotta, P; Auerbach, S; Barkin, J; Carson, CC; Colopy, MW; Hatzichristou, DG; Lording, D; McBride, TA; Murdock, M; Wilkins, HJ, 2005)
"25 hour after dosing (62% vs 30%); efficacy continued beyond 6 hours after dosing in 77% and 50% of patients, respectively."	( Erectile response to vardenafil in men with a history of nonresponse to sildenafil: a time-from-dosing descriptive analysis. Aliotta, P; Auerbach, S; Barkin, J; Carson, CC; Colopy, MW; Hatzichristou, DG; Lording, D; McBride, TA; Murdock, M; Wilkins, HJ, 2005)
"25 hour and lasted for >6 hours after dosing with vardenafil 10 mg in these men with mostly moderate to severe ED and a history of nonresponse to sildenafil and who chose to make attempts during those intervals."	( Erectile response to vardenafil in men with a history of nonresponse to sildenafil: a time-from-dosing descriptive analysis. Aliotta, P; Auerbach, S; Barkin, J; Carson, CC; Colopy, MW; Hatzichristou, DG; Lording, D; McBride, TA; Murdock, M; Wilkins, HJ, 2005)
" Initial dosage was vardenafil 10 mg for 4 weeks."	( Vardenafil improves satisfaction rates, depressive symptomatology, and self-confidence in a broad population of men with erectile dysfunction. Bandel, TJ; Buvat, J; Cuzin, B; Hatzichristou, D; Laferriere, N; Martin-Morales, A; Montorsi, F; Porst, H, 2005)
" Of considerable interest to patients and physicians is an understanding of the time required after dosing to attain penile erection sufficient for successful sexual intercourse."	( Earliest time to onset of action leading to successful intercourse with vardenafil determined in an at-home setting: a randomized, double-blind, placebo-controlled trial. Bandel, TJ; Beneke, M; Buvat, J; Montorsi, F; Padma-Nathan, H; Porst, H; Schwaibold, H; Ulbrich, E, 2004)
" Using a stopwatch, patients recorded the elapsed time from dosing to attainment of an erection perceived to be adequate for penetration that led to intercourse completion."	( Earliest time to onset of action leading to successful intercourse with vardenafil determined in an at-home setting: a randomized, double-blind, placebo-controlled trial. Bandel, TJ; Beneke, M; Buvat, J; Montorsi, F; Padma-Nathan, H; Porst, H; Schwaibold, H; Ulbrich, E, 2004)
" In a retrospective analysis using time intervals of	( Earliest time to onset of action leading to successful intercourse with vardenafil determined in an at-home setting: a randomized, double-blind, placebo-controlled trial. Bandel, TJ; Beneke, M; Buvat, J; Montorsi, F; Padma-Nathan, H; Porst, H; Schwaibold, H; Ulbrich, E, 2004)
" Phase 2: true non-responders were given new instructions based on drugs' pharmacologic profiles: TGs were dosed at least 2 h before intercourse; VGs were dosed only in fasted state."	( Treatment strategy for "non-responders" to tadalafil and vardenafil: a real-life study. Bekos, A; Hatzichristou, D; Hatzimouratidis, K; Ioannidis, E; Moysidis, K; Tsimtsiou, Z, 2006)
" Phase 2, 22 of 88 (25%) responded to dosing in a fasted state."	( Treatment strategy for "non-responders" to tadalafil and vardenafil: a real-life study. Bekos, A; Hatzichristou, D; Hatzimouratidis, K; Ioannidis, E; Moysidis, K; Tsimtsiou, Z, 2006)
"5, 3, 4, 6, 8, 10, 12, 15 and 24 h post dosing using a validated oscillometric sphygmomanometer."	( Simultaneous administration of vardenafil and alcohol does not result in a pharmacodynamic or pharmacokinetic interaction in healthy male subjects. Bauer, R; Heinig, R; Rohde, G; Unger, S; Wensing, G, 2006)
" The dosage level of piperidenafil in the herbal product was 41 mg per capsule when calculated as the free base."	( Use of liquid chromatography-mass spectrometry and a hydrolytic technique for the detection and structure elucidation of a novel synthetic vardenafil designer drug added illegally to a "natural" herbal dietary supplement. Reepmeyer, JC; Woodruff, JT, 2006)
" Only 7 (12%) of the 59 men reported that home vardenafil dosing resulted in successful intercourse."	( Vardenafil rescue rates of sildenafil nonresponders: objective assessment of 327 patients with erectile dysfunction. Brisson, TE; Broderick, GA; Heckman, MG; Pinkstaff, DM; Thiel, DD, 2006)
" Infusion of the NO synthase blocker L-NMMA (100 microM) caused a rightward shift of the dose-response curve of vardenafil."	( Vardenafil increases coronary flow response to hypercapnic acidosis in isolated guinea pig heart. Brand, M; Deussen, A, 2007)
"Vardenafil has higher affinity to phosphodiesterase-5 (PDE5) than sildenafil and lower administered dosage for the treatment of erectile dysfunction."	( Conformational variations of both phosphodiesterase-5 and inhibitors provide the structural basis for the physiological effects of vardenafil and sildenafil. Francis, SH; Ke, H; Robinson, H; Wang, H; Ye, M, 2008)
"To test the hypothesis that a variable dosage of the oral phosphodiesterase type 5 (PDE5) inhibitor sildenafil (25, 50, 100 mg) or vardenafil (5, 10, 25 mg) determined according to results obtained from nocturnal penile tumescence and rigidity (NPTR, RigiScan), given nightly for 1 year, can improve spontaneous erectile function (EF) in men with mild-to-moderate arteriogenic erectile dysfunction (ED); this regimen was compared with a fixed daily dosage of sildenafil 25 mg or vardenafil 5 mg."	( Long-term treatment of erectile dysfunction with a phosphodiesterase-5 inhibitor and dose optimization based on nocturnal penile tumescence. Brandt, AS; Klotz, T; Mathers, MJ; Roth, S; Sommer, F, 2008)
"In a prospective open-label, parallel-group trial 154 men with ED were randomized either to fixed low-dose sildenafil 25 mg or vardenafil 5 mg (group 1) or to the lowest erectile dosage of sildenafil (25, 50 or 100 mg) or vardenafil (5, 10 or 20 mg) (group 2) provoking an erectile event as measured by NPTR nightly for 1 year."	( Long-term treatment of erectile dysfunction with a phosphodiesterase-5 inhibitor and dose optimization based on nocturnal penile tumescence. Brandt, AS; Klotz, T; Mathers, MJ; Roth, S; Sommer, F, 2008)
"Nightly PDE5-inhibitor treatment 1 year in a dosage determined by NPTR measurements results in better EF than giving a fixed dosage of sildenafil (25 mg) or vardenafil (5 mg)."	( Long-term treatment of erectile dysfunction with a phosphodiesterase-5 inhibitor and dose optimization based on nocturnal penile tumescence. Brandt, AS; Klotz, T; Mathers, MJ; Roth, S; Sommer, F, 2008)
" This finding may serve as a basis for further work evaluating the utility of chronic vardenafil dosing in diabetic men."	( Endothelial rehabilitation: the impact of chronic PDE5 inhibitors on erectile function and protein alterations in cavernous tissue of diabetic rats. Brock, GB; Carson, J; De Young, LX; Domes, T; Lim, K, 2008)
" Once-daily dosing has been suggested to benefit patients."	( Comparable efficacy of once-daily versus on-demand vardenafil in men with mild-to-moderate erectile dysfunction: findings of the RESTORE study. Beneke, M; Grohmann, W; Porst, H; Sommer, F; Ulbrich, E; Zumbé, J, 2008)
"Once-daily vardenafil did not produce greater sustained effects on EF than on-demand vardenafil in men with mild-to-moderate ED, suggesting that daily dosing of PDE5 inhibitors does not produce sustained clinical benefits beyond cessation of treatment above those observed with on-demand administration."	( Comparable efficacy of once-daily versus on-demand vardenafil in men with mild-to-moderate erectile dysfunction: findings of the RESTORE study. Beneke, M; Grohmann, W; Porst, H; Sommer, F; Ulbrich, E; Zumbé, J, 2008)
"To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED)."	( Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Brock, G; Graefen, M; Lee, J; Montorsi, F; Shapiro, J; Stief, C; Van Poppel, H, 2008)
"To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery."	( Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Brock, G; Graefen, M; Lee, J; Montorsi, F; Shapiro, J; Stief, C; Van Poppel, H, 2008)
"In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group."	( Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Brock, G; Graefen, M; Lee, J; Montorsi, F; Shapiro, J; Stief, C; Van Poppel, H, 2008)
" Interestingly, at higher doses, R(max) to acetylcholine was attenuated leading to U-shaped dose-response curves."	( Dose-dependent effects of a selective phosphodiesterase-5-inhibitor on endothelial dysfunction induced by peroxynitrite in rat aorta. Arif, R; Barnucz, E; Hirschberg, K; Karck, M; Korkmaz, S; Loganathan, S; Neugebauer, P; Radovits, T; Seidel, B; Szabó, G, 2009)
" The focus of this article is on updates on regular dosing regimens of PDE5I other than the newly approved daily dose tadalafil."	( 2009 update on phosphodiesterase type 5 inhibitor therapy part 1: Recent studies on routine dosing for penile rehabilitation, lower urinary tract symptoms, and other indications (CME). Shindel, AW, 2009)
"" Articles were screened based on whether or not they addressed issues of routine dosing of PDE5I."	( 2009 update on phosphodiesterase type 5 inhibitor therapy part 1: Recent studies on routine dosing for penile rehabilitation, lower urinary tract symptoms, and other indications (CME). Shindel, AW, 2009)
"Peer reviewed publications on routine dosing of PDE5I published in the medical literature since 2007."	( 2009 update on phosphodiesterase type 5 inhibitor therapy part 1: Recent studies on routine dosing for penile rehabilitation, lower urinary tract symptoms, and other indications (CME). Shindel, AW, 2009)
"There have been numerous publications in the past 2 years regarding routine dosing of PDE5I for three major urological indications; penile rehabilitation, stuttering priapism, and management of lower urinary tract symptoms (LUTS)."	( 2009 update on phosphodiesterase type 5 inhibitor therapy part 1: Recent studies on routine dosing for penile rehabilitation, lower urinary tract symptoms, and other indications (CME). Shindel, AW, 2009)
" It is unclear whether the results can be applied to difficult-to-treat ED patients, such as those with diabetes mellitus (DM), with the time between dosing and insertion into vagina."	( Vardenafil allows successful intercourse initiated rapidly after dosing in Japanese patients with diabetes mellitus and erectile dysfunction. Brant, WO; Fujikawa, K; Ishii, N; Iwamoto, Y; Kamidono, S; Kobayashi, H; Nagao, K; Tachibana, T; Turek, PJ, 2009)
" Mean per-patient SEP-3 success rates (intent-to-treat; ITT population), based on patient diary question, were calculated by the time between dosing and insertion."	( Vardenafil allows successful intercourse initiated rapidly after dosing in Japanese patients with diabetes mellitus and erectile dysfunction. Brant, WO; Fujikawa, K; Ishii, N; Iwamoto, Y; Kamidono, S; Kobayashi, H; Nagao, K; Tachibana, T; Turek, PJ, 2009)
" Daily dosing may be useful in some men; however, the other available PDE5I continue to show excellent efficacy in the management of erectile dysfunction (ED)."	( 2009 update on phosphodiesterase type 5 inhibitor therapy part 2: updates on optimal utilization for sexual concerns and rare toxicities in this class. Shindel, AW, 2009)
"The effect of vardenafil on hypoxia-induced alterations was studied in vivo in SHR by acute dosing (10 mg/kg, 90 minutes before sacrifice) and in vitro in human bladder smooth muscle cells (hBCs)."	( Acute vardenafil administration improves bladder oxygenation in spontaneously hypertensive rats. Carini, M; Chavalmane, AK; Comeglio, P; Fibbi, B; Filippi, S; Gacci, M; Maggi, M; Morelli, A; Sandner, P; Sarchielli, E; Silvestrini, E; Vannelli, GB; Vignozzi, L, 2010)
" Multiple dosing or administration of vardenafil ODT with food had no meaningful effect on the pharmacokinetics of vardenafil."	( Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Böttcher, MF; Dietrich, H; Heinig, R; Weimann, B, 2011)
" Time intervals (in 15-, 30-, and 60-minute increments, up to ≥6 hours after study medication intake) were determined for the period between dosing and start of sexual activity (with the intention of intercourse)."	( Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. Beneke, M; Börner, M; Debruyne, FM; Gittelman, M; Sperling, H, 2011)
" In the present study, we investigated the effects of vardenafil on myocardial contractility and vascular function in a dose-response study."	( Enhancement of myocardial and vascular function after phosphodiesterase-5 inhibition in a rat model. Arif, R; Barnucz, E; Bömicke, T; Hirschberg, K; Karck, M; Korkmaz, S; Loganathan, S; Radovits, T; Szabó, G; Weymann, A, 2012)
" Compounds were dosed 30 min before the learning trial of the task."	( Phosphodiesterase type 5 (PDE5) inhibition improves object recognition memory: indications for central and peripheral mechanisms. Akkerman, S; Blokland, A; Menniti, FS; Prickaerts, J; Reneerkens, OA; Rutten, K; Shaffer, CL; Steinbusch, HW, 2012)
" In this study doubling the dosage did not improve the recovery of EF further."	( Increasing the dose of vardenafil on a daily basis does not improve erectile function after unilateral nerve-sparing radical prostatectomy. Bannowsky, A; Loch, T; van Ahlen, H, 2012)
" There is level 5 evidence (expert opinion) that combination therapy of PDE5 inhibitors + L-arginine or daily dosing of tadalafil + short-acting PDE5 inhibitors pro re nata may rescue PDE5 inhibitor monotherapy failures."	( SOP conservative (medical and mechanical) treatment of erectile dysfunction. Brock, G; Burnett, A; Ghanem, H; Giuliano, F; Glina, S; Hellstrom, W; Martin-Morales, A; Porst, H; Salonia, A; Sharlip, I, 2013)
" Cardioprotective effects were found over a broad dosage range."	( Pharmacological postconditioning by bolus injection of phosphodiesterase-5 inhibitors vardenafil and sildenafil. Böhme, S; Ebner, A; Ebner, B; Reetz, A; Schauer, A; Strasser, RH; Weinbrenner, C, 2013)
"To assess persistence/adherence rates of phosphodiesterase type-5 inhibitor (PDE5I) on-demand dosing in Latin American men with erectile dysfunction (ED), and explore patient characteristics and treatment factors that may be predictive for PDE5I persistence and adherence."	( A 6 month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Latin American men with erectile dysfunction. Borregales, L; Cairoli, C; Reyes, LA; Rubio-Aurioles, E; Sorsaburu, S, 2013)
"Men from Brazil, Mexico, and Venezuela with ED who were naïve to PDE5Is were prescribed sildenafil, tadalafil, vardenafil, or lodenafil on-demand dosing and asked to provide information about PDE5I use at baseline and at 1, 3, and 6 months."	( A 6 month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Latin American men with erectile dysfunction. Borregales, L; Cairoli, C; Reyes, LA; Rubio-Aurioles, E; Sorsaburu, S, 2013)
" Persistence was defined as use of ≥1 dose during the prior 4 weeks, adherence as compliance with dosing instructions during the most recent dose."	( A 6-month, prospective, observational study of PDE5 inhibitor treatment persistence and adherence in Middle Eastern and North African men with erectile dysfunction. Al-Mitwalli, K; El-Meliegy, A; Gurbuz, S; Hussein, T; Istarabadi, M; Lei, Y; Mostafa, T; Rabah, D, 2013)
"The arsenal of professionals providing assistance to men with erectile dysfunction includes a new, mouth dissolving dosage form of the vardenafil--levitra ODT."	( [Levitra (oral dispersible tablet)--an innovative drug for the treatment of patients with erectile dysfunction]. Korneev, IA, )
" T and OCA dosing in HFD rabbits both reduced TNFα liver expression and plasma levels, with a parallel increase of penile eNOS expression and responsiveness to Ach."	( Nonalcoholic steatohepatitis as a novel player in metabolic syndrome-induced erectile dysfunction: an experimental study in the rabbit. Adorini, L; Cellai, I; Comeglio, P; Filippi, S; Galli, A; Maggi, M; Maneschi, E; Mannucci, E; Morelli, A; Rastrelli, G; Saad, F; Sarchielli, E; Vannelli, GB; Vignozzi, L, 2014)
" In addition, vardenafil attenuated both Phe or KCl-induced contraction but, it's effect on the KCl dose-response curve was more significant."	( An evaluation of vardenafil as a calcium channel blocker in pulmonary artery in rats. Minareci, E; Sadan, G, )
" Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire."	( PDE5 inhibitor treatment persistence and adherence in Brazilian men: post-hoc analyses from a 6-month, prospective, observational study. Cairoli, C; Henneges, C; Reyes, LA; Sorsaburu, S, )
" Sildenafil (SIL) and vardenafil (VAR) are approved for as-needed (PRN) dosing; tadalafil (TAD) is approved for both PRN and once-a-day (OaD) dosing for ED."	( Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. Baygani, S; Burns, P; Goldfischer, E; Kim, E; Seftel, A, 2015)
"A valid, sensitive and rapid spectrofluorimetric method has been developed and validated for determination of both tadalafil (TAD) and vardenafil (VAR) either in their pure form, in their tablet dosage forms or spiked in human plasma."	( Validated spectrofluorimetric method for determination of two phosphodiesterase inhibitors tadalafil and vardenafil in pharmaceutical preparations and spiked human plasma. Abu El-Enin, MA; Al-Ghaffar Hammouda, Mel-S; El-Ashry, SM; El-Sherbiny, DT; El-Wasseef, DR, 2016)
" We found that PO vardenafil restored a scopolamine-induced memory impairment when dosed within 2 min after the learning trial while ICV vardenafil was able to restore memory when injected within 4 min after learning."	( PDE5 inhibition improves acquisition processes after learning via a central mechanism. Akkerman, S; Blokland, A; Cremers, P; Osgood, SM; Prickaerts, J; Shaffer, CL; Steinbusch, HW; van Goethem, NP, 2015)
"Vesicular drug delivery systems have recently gained attention as a way of improving dosing accuracy for drugs with poor transdermal permeation."	( Nanoethosomal transdermal delivery of vardenafil for treatment of erectile dysfunction: optimization, characterization, and in vivo evaluation. Fahmy, UA, 2015)
" Because various PDE5Is vary in their duration of action and dosage regimen, this may be an important consideration in selecting the optimal agent for the ED patient."	( Sexual habits of men with ED who take phosphodiesterase 5 inhibitors: a survey conducted in 7 countries. Hassan, TA; Mulhall, JP; Rienow, J, 2018)
" The time to sexual intercourse after dosing was ≤1 hour for 70% and ≤4 hours for 96% of men."	( Sexual habits of men with ED who take phosphodiesterase 5 inhibitors: a survey conducted in 7 countries. Hassan, TA; Mulhall, JP; Rienow, J, 2018)
" The developed method was successfully applied to determine the studied drugs in dosage forms and human plasma samples and the results were satisfactory as revealed by statistical analysis of the data."	( Simultaneous HPLC determination of alfuzosin, tamsulosin and vardenafil in human plasma and pharmaceutical formulations using time programmed fluorescence detection. Belal, F; Borg, H; Fathy, M; Walash, MI; Zayed, S, 2019)
"The present work aims to develop and validate a simple, rapid, cost-effective, sensitive and extractive spectrophotometric methods for the determination of phosphodiesterase type 5-inhibitor; vardenafil HCl (VARD) in pure and in dosage forms."	( Sensitive spectrophotometric determination of vardenafil HCl in pure and dosage forms. Abdel Haleem, DS; El-Malla, SF; Gouda, AA; Mabrouk, MM, 2021)
"The proposed methods have been applied successfully for the analysis of vardenafil HCl in pure and dosage forms."	( Sensitive spectrophotometric determination of vardenafil HCl in pure and dosage forms. Abdel Haleem, DS; El-Malla, SF; Gouda, AA; Mabrouk, MM, 2021)
"We carried out this systemic review and meta-analysis of relevant randomized controlled trials to determine different dosage regimens of vardenafil in the treatment of male erectile dysfunction (ED)."	( Vardenafil in the Treatment of Male Erectile Dysfunction: A Systematic Review and Meta-Analysis. Guo, B; Huang, Z; Ji, Z; Wang, H; Zhao, X, 2021)
" The article also discusses the methods for preparation of lodenafil, its physical-chemical properties, analytical methods for its determination, pharmacological-toxicological properties, and dosing information."	( Lodenafil. Al-Majed, AA; Alshehri, YM; Attwa, MW; Bakheit, AH, 2022)

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	383 (53.72)	29.6817
2010's	276 (38.71)	24.3611
2020's	54 (7.57)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	151 (19.36%)	5.53%
Reviews	140 (17.95%)	6.00%
Case Studies	32 (4.10%)	4.05%
Observational	7 (0.90%)	0.25%
Other	450 (57.69%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (78)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4[NCT01110590]	Phase 1	37 participants (Actual)	Interventional	2010-01-31	Completed
Therapeutic Effectiveness of Vardenafil in ED Patients With the Metabolic Syndrome in Daily Clinical Practice[NCT01106118]		2,289 participants (Actual)	Observational	2010-01-31	Completed
LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers[NCT01207947]		491 participants (Actual)	Observational	2007-10-31	Completed
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery[NCT01260285]	Phase 1	10 participants (Actual)	Interventional	2010-12-31	Completed
An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)[NCT02450188]	Phase 4	30 participants (Actual)	Interventional	2012-03-31	Completed
Correlation of Flow Mediated Dilation of Brachial Artery and Carotid Intima Media Thickness With Erectile Dysfunction Severity and Clinical Response to PDE 5 Inhibitor in Hypertensive Men[NCT01084187]	Phase 4	100 participants (Actual)	Interventional	2010-01-31	Completed
Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.[NCT00665054]	Phase 4	160 participants (Actual)	Interventional	2004-08-31	Completed
Vardenafil in Routine Treatment of Erectile Dysfunction[NCT01215409]		372 participants (Actual)	Observational	2008-02-29	Terminated(stopped due to Slow recruitment)
A Double-Blind Study to Evaluate the Pharmacodynamic Interaction Between 10 mg Vardenafil ODT (Orally Disintegrating Tablet) and Procardia XL® (Nifedipine GITS) in Elderly Male Patients With Both Hypertension and Erectile Dysfunction[NCT01348880]	Phase 1	42 participants (Actual)	Interventional	2011-05-31	Completed
A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction [NCT01168817]	Phase 2	140 participants (Actual)	Interventional	2010-08-31	Completed
Double-blind, Placebo-controlled Cross-over Study to Investigate the Effects of the Phosphodiesterase 5-inhibitor Vardenafil on Periphery Blood Flow and Clinical Symptoms of Patients With Raynaud's Syndrome[NCT01291199]	Phase 2/Phase 3	57 participants (Actual)	Interventional	2006-11-30	Completed
Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)[NCT00738400]	Phase 4	150 participants (Actual)	Interventional	2008-11-30	Completed
A Randomized, Double Blind, Parallel Group, Multi-center Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction, and Their Female Partners' Sexual Quality of Life.[NCT00657033]	Phase 3	229 participants (Actual)	Interventional	2003-10-31	Completed
An Open-label, Multi-center, Factorial Design, Cluster-randomized Clinical Study of Vardenafil in Canadian Males With Erectile Dysfunction: Impact of Education of the Primary Care Physician and Patient on Patient Outcomes.[NCT00664833]	Phase 4	1,029 participants (Actual)	Interventional	2004-05-31	Completed
A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED[NCT00786253]	Phase 2	236 participants (Actual)	Interventional	2005-10-31	Completed
An Open-Label Phase I/IIa Study to Assess the Safety and Tolerability Profile of TR399 in Healthy Volunteers and Erectile Dysfunction Patients[NCT03102398]	Phase 1/Phase 2	26 participants (Anticipated)	Interventional	2017-03-31	Recruiting
Phase IV: Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism[NCT01084369]	Phase 4	22 participants (Actual)	Interventional	2013-10-11	Terminated(stopped due to Withdrawal of sponsorship)
Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study.[NCT01002534]	Phase 2	5 participants (Actual)	Interventional	2011-10-31	Terminated(stopped due to not yet started)
A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia[NCT00668109]	Phase 3	614 participants (Actual)	Interventional	2003-12-31	Completed
A Randomized, Double-blind, Placebo Controlled, Parallel Arm, Multicenter Trial Assessing the Effect of Daily Treatment of Vardenafil 20 mg or Sildenafil 100 mg Compared to Placebo on Spermatogenesis[NCT00655590]	Phase 4	200 participants (Actual)	Interventional	2005-01-31	Completed
Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction[NCT00661596]	Phase 3	129 participants (Actual)	Interventional	2003-05-31	Completed
A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.[NCT00665340]	Phase 4	219 participants (Actual)	Interventional	2004-07-31	Completed
A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.[NCT00665496]	Phase 3	732 participants (Actual)	Interventional	2003-06-30	Completed
REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy[NCT00874679]		7,293 participants (Actual)	Observational	2007-03-31	Completed
LEVITRA® 20mg Special Drug Use Investigation (Long-term)[NCT00909233]		1,221 participants (Actual)	Observational	2007-08-31	Completed
A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction[NCT00678704]	Phase 3	790 participants (Actual)	Interventional	2004-01-31	Completed
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia[NCT00657839]	Phase 2	222 participants (Actual)	Interventional	2005-10-31	Completed
A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .[NCT00661115]	Phase 3	173 participants (Actual)	Interventional	2003-05-31	Completed
Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study[NCT00666809]	Phase 2	43 participants (Actual)	Interventional	2006-10-31	Completed
Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals[NCT00662441]	Phase 4	102 participants (Actual)	Interventional	2003-09-30	Completed
A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED[NCT00667979]	Phase 4	264 participants (Actual)	Interventional	2004-09-30	Completed
Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction[NCT00668057]	Phase 3	624 participants (Actual)	Interventional	2002-12-31	Completed
Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia[NCT00668135]	Phase 4	348 participants (Actual)	Interventional	2003-03-31	Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemi[NCT00663845]	Phase 4	395 participants (Actual)	Interventional	2006-05-31	Completed
[NCT00705588]	Phase 4	30 participants (Anticipated)	Interventional	2008-08-31	Not yet recruiting
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction[NCT00682019]	Phase 3	383 participants (Actual)	Interventional	2003-12-31	Completed
A Phase 2a, Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension[NCT05343637]	Phase 2	14 participants (Actual)	Interventional	2019-07-30	Completed
A Randomized Double-blind Multi-center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.[NCT00661219]	Phase 3	280 participants (Actual)	Interventional	2002-12-31	Completed
A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction[NCT00661297]	Phase 3	523 participants (Actual)	Interventional	2003-06-30	Completed
A Randomized, Double-blind, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administration for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Men With Arterial Hypertension and Erectile Dysfunction[NCT00668005]	Phase 3	388 participants (Actual)	Interventional	2003-02-28	Completed
Sustained Improvement of MYocardial Blood Flow by Intermittent PhosphoDiesterase 5 INhibition in REfractory Coronary ArterY Disease Suggests Enhanced Angiogenesis (SYDNEY)[NCT01406535]		0 participants	Expanded Access		Temporarily not available
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects[NCT00767598]	Phase 1	21 participants (Actual)	Interventional	2007-12-31	Completed
A Randomized, Double-blind, Parallel Group Prospective Pilot Study to Assess the Effect of Vardenafil on Clinical Outcome and on Procedure Duration After Green Light Laser-ablation of the Prostate Gland for Therapy of Benign Prostate Hypertrophy (BPH)[NCT00461123]	Phase 2	50 participants (Actual)	Interventional	2007-03-31	Completed
Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder (Detrusor Overactivity)[NCT00478881]	Phase 2	397 participants (Actual)	Interventional	2007-08-31	Completed
Monitoring of Endothelial Dysfunction During Chronic Administration of Vardenafil in Patients With Type 2 Diabetes Mellitus: A Longitudinal, Randomised, Placebo-controlled, Double Blind, Phase II b, Clinical Trial[NCT02219646]	Phase 2	54 participants (Actual)	Interventional	2010-03-31	Completed
[NCT01649739]	Phase 4	20 participants (Anticipated)	Interventional	2012-09-30	Not yet recruiting
Multi-centre, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Treatment of Pulmonary Arterial Hypertension With Vardenafil in China[NCT00718952]	Phase 3	60 participants (Anticipated)	Interventional	2008-07-31	Completed
Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial[NCT00655629]	Phase 3	339 participants (Actual)	Interventional	2008-04-30	Completed
Multi-Centre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury[NCT00725790]	Phase 4	350 participants (Anticipated)	Interventional	2008-08-31	Not yet recruiting
An Open, Multi-centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction[NCT00652262]	Phase 3	32 participants (Actual)	Interventional	2004-03-31	Completed
Open-label Multi-centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-dose Regimen in Males With Erectile Dysfunction of Broad Aetiology.[NCT00657644]	Phase 3	130 participants (Actual)	Interventional	2003-08-31	Completed
A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury[NCT00654680]	Phase 3	418 participants (Actual)	Interventional	2002-10-31	Completed
A National, Multicentre, Open Label, Flexible Dose, Twelve Week Treatment to Assess the Efficacy and Safety of 5mg, 10mg and 20mg Bay 38-9456, a Phosphodiesterase Type V Inhibitor, in the Treatment of Male Patients With Erectile Dysfunction[NCT00654914]	Phase 3	527 participants (Actual)	Interventional	2003-05-31	Completed
A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Men With Diabetes Mellitus Type 1 and Erectile Dysfunction[NCT00660998]	Phase 4	318 participants (Actual)	Interventional	2003-02-28	Completed
"A Double-blind Preferred Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction"[NCT00661700]	Phase 3	611 participants (Actual)	Interventional	2003-04-30	Completed
An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug[NCT00668018]	Phase 3	887 participants (Actual)	Interventional	2003-01-31	Completed
A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.[NCT00668096]	Phase 4	260 participants (Actual)	Interventional	2004-05-31	Completed
A Randomized, Double-blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED[NCT00663728]	Phase 4	201 participants (Actual)	Interventional	2004-09-30	Completed
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects[NCT00658177]	Phase 3	463 participants (Actual)	Interventional	2003-06-30	Completed
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects[NCT00656188]	Phase 2/Phase 3	463 participants (Actual)	Interventional	2002-10-31	Completed
A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)[NCT01131104]		345 participants (Actual)	Observational	2010-05-31	Completed
A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction[NCT00663130]	Phase 4	759 participants (Actual)	Interventional	2004-04-30	Completed
Double-blind, Cross-over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEM[NCT00667966]	Phase 4	45 participants (Actual)	Interventional	2005-07-31	Completed
REALISE Levitra® - Real Life Safety and Efficacy of Levitra[NCT00663598]	Phase 4	30,825 participants (Actual)	Interventional	2003-10-31	Completed
Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction[NCT00681772]	Phase 4	333 participants (Actual)	Interventional	2003-03-31	Completed
A Double Blind, Randomized, Placebo Controlled, Two Part, Two Session Balanced, Crossover Study to Evaluate Visual Changes in Healthy Male Subjects Aged 18 - 55 Years After Receiving: 1. at Least 15 Doses of 20 mg Vardenafil, Compared to Placebo and 2. Tw[NCT00461565]	Phase 4	63 participants (Actual)	Interventional	2005-02-28	Completed
A Randomized, Double-blind, Double-dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving Erectile F[NCT00492635]	Phase 3	628 participants (Actual)	Interventional	2004-12-31	Completed
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS for the Treatment of Benign Prostatic Hyperplasia[NCT00517179]		40 participants (Anticipated)	Interventional	2006-04-30	Completed
A Phase 1, Two-Part, Single-Center, Open-Label, Randomized, Cross-Over, Single Ascending Doses (SAD), Followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects[NCT05567367]	Phase 1	31 participants (Actual)	Interventional	2018-07-31	Completed
A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Obtain Data on Safety and Efficacy of Levitra® in Routine Treatment of Erectile Dysfunction in Depressive and Non-Depressive Men.[NCT00470873]		2,471 participants (Actual)	Observational	2007-01-31	Completed
A Prospective, Randomized, 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Treatment[NCT00498680]	Phase 4	46 participants (Anticipated)	Interventional	2007-03-31	Recruiting
CSMC IIT: Pilot Study of Phosphodiesterase-V Inhibition to Increase Intratumoral Concentration of Carboplatin in Patients With Recurrent High Grade Gliomas and Brain Metastases[NCT02279992]	Early Phase 1	7 participants (Actual)	Interventional	2012-03-27	Terminated(stopped due to Unable to accrue to the study. Original PI no longer with the institute.)
A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II[NCT00377793]	Phase 4	352 participants (Actual)	Interventional	2006-07-31	Completed
A Phase 2b, Open-label, Single Dose Study to Evaluated the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing (CPET) in Subjects With Pulmonary Arterial Hypertension (PAH)[NCT04266197]	Phase 2	86 participants (Anticipated)	Interventional	2020-09-25	Recruiting
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemi[NCT00379756]	Phase 4	395 participants (Actual)	Interventional	2006-05-22	Completed
Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I[NCT00631969]	Phase 3	362 participants (Actual)	Interventional	2008-04-30	Completed
Effect of Vardenafil on Erectile Dysfunction and Portal Hemodynamics in Patients With Liver Cirrhosis[NCT02344823]	Phase 4	30 participants (Anticipated)	Interventional	2012-06-30	Recruiting
A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc[NCT00853840]	Phase 4	18 participants (Actual)	Interventional	2008-04-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00461123 (5) [back to overview]	Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
NCT00461123 (5) [back to overview]	Duration of Surgery
NCT00461123 (5) [back to overview]	Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
NCT00461123 (5) [back to overview]	Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
NCT00461123 (5) [back to overview]	Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
NCT00478881 (10) [back to overview]	Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Volume at First Detectable Leakage at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older
NCT00478881 (10) [back to overview]	Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Volume at First Desire to Void at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Average Number of Daily Micturitions at 6 Weeks
NCT00478881 (10) [back to overview]	Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks
NCT00631969 (20) [back to overview]	Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
NCT00631969 (20) [back to overview]	"Percentage of Subjects Achieving Back to Normal Erectile Function"
NCT00631969 (20) [back to overview]	Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
NCT00631969 (20) [back to overview]	Change From Baseline in Ease With Erection at 12 Weeks or LOCF
NCT00631969 (20) [back to overview]	Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
NCT00631969 (20) [back to overview]	Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
NCT00631969 (20) [back to overview]	Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
NCT00631969 (20) [back to overview]	Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
NCT00631969 (20) [back to overview]	Change From Baseline in Success of Erection Maintenance at 12 Weeks
NCT00631969 (20) [back to overview]	Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
NCT00631969 (20) [back to overview]	Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
NCT00631969 (20) [back to overview]	Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
NCT00631969 (20) [back to overview]	Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
NCT00631969 (20) [back to overview]	Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
NCT00631969 (20) [back to overview]	Number of Sexual Attempts Till First Successful Attempt
NCT00631969 (20) [back to overview]	Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
NCT00631969 (20) [back to overview]	Satisfaction With Medication at Week 12 or LOCF
NCT00631969 (20) [back to overview]	Change in Percentage From Baseline in Success of Penetration at 12 Weeks
NCT00631969 (20) [back to overview]	Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
NCT00631969 (20) [back to overview]	Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
NCT00655629 (16) [back to overview]	Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
NCT00655629 (16) [back to overview]	"Percentage of Subjects Achieving Back to Normal Erectile Function"
NCT00655629 (16) [back to overview]	Change From Baseline in Ease With Erection at 12 Weeks or LOCF
NCT00655629 (16) [back to overview]	Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
NCT00655629 (16) [back to overview]	Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
NCT00655629 (16) [back to overview]	Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
NCT00655629 (16) [back to overview]	Change From Baseline in Success of Erection Maintenance at 12 Weeks
NCT00655629 (16) [back to overview]	Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
NCT00655629 (16) [back to overview]	Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
NCT00655629 (16) [back to overview]	Satisfaction With Medication at Week 12 or LOCF
NCT00655629 (16) [back to overview]	Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
NCT00655629 (16) [back to overview]	Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
NCT00655629 (16) [back to overview]	Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
NCT00655629 (16) [back to overview]	Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
NCT00655629 (16) [back to overview]	Number of Sexual Attempts Till First Successful Attempt
NCT00655629 (16) [back to overview]	Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
NCT00738400 (7) [back to overview]	Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)
NCT00738400 (7) [back to overview]	Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8
NCT00738400 (7) [back to overview]	Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8
NCT00738400 (7) [back to overview]	Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8
NCT00738400 (7) [back to overview]	Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8
NCT00738400 (7) [back to overview]	Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))
NCT00738400 (7) [back to overview]	"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"
NCT00853840 (5) [back to overview]	Number of Subjects With Postural Hypotension
NCT00853840 (5) [back to overview]	Postural Changes in Pulse Rate
NCT00853840 (5) [back to overview]	Postural Changes in Systolic and Diastolic Blood Pressure
NCT00853840 (5) [back to overview]	Standing and Supine Pulse Rate
NCT00853840 (5) [back to overview]	Standing and Supine Systolic and Diastolic Blood Pressure (BP)
NCT01131104 (1) [back to overview]	30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use

Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst). (NCT00461123)
Timeframe: baseline and up to 3 months after surgery

Intervention	scores on a scale (Mean)
	baseline mean	Day +90 or LOCF mean
Placebo	19.7	6.7
Vardenafil (Levitra, BAY38-9456)	19.1	6.9

Intervention	μg/L (Geometric Mean)
ED Patients Aged < 65 Years	10.09
ED Patients Aged ≥ 65 Years	13.43

Intervention	percentage of participants (Number)
	<65 years	≥65 years	Total
Placebo	13	11	12
Vardenafil ODT (STAXYN, BAY38-9456)	46	34	40

Intervention	μg*h/L (Geometric Mean)
ED Patients Aged < 65 Years	47.16
ED Patients Aged ≥ 65 Years	55.37

Intervention	µg*h/L (Geometric Mean)
ED Patients Aged < 65 Years	33.36
ED Patients Aged ≥ 65 Years	41.80

Intervention	µg/L (Geometric Mean)
ED Patients Aged < 65 Years	9.260
ED Patients Aged ≥ 65 Years	11.47

Intervention	percentage of subjects (Number)
	<65 years	>=65 years	Total
Placebo	11	8	9
Vardenafil ODT (STAXYN, BAY38-9456)	59	32	46

Intervention	participants (Number)
Maraviroc + Vardenafil (Treatment A)	0
Maraviroc + Placebo (Treatment B)	0

Intervention	beats per minute (bpm) (Mean)
	Baseline	6 hours	12 hours
Maraviroc + Placebo (Treatment B)	14.3	20.4	12.0
Maraviroc + Vardenafil (Treatment A)	16.0	22.9	12.0

Intervention	mm Hg (Mean)
	Systolic Blood Pressure: Baseline	Diastolic Blood Pressure: Baseline	Systolic Blood Pressure: 6 hours	Diastolic Blood Pressure: 6 hours	Systolic Blood Pressure: 12 hours	Diastolic Blood Pressure: 12 hours
Maraviroc + Placebo (Treatment B)	2.6	7.5	1.5	9.6	3.5	9.9
Maraviroc + Vardenafil (Treatment A)	3.5	8.9	2.2	8.4	5.9	11.4

Intervention	beats per minute (bpm) (Least Squares Mean)
	Supine pulse rate: 1.5 hours post Maraviroc dose	Supine pulse rate: 2 hours post Maraviroc dose	Supine pulse rate: 2.5 hours post Maraviroc dose	Supine pulse rate: 3 hours post Maraviroc dose	Supine pulse rate: 4 hours post Maraviroc dose	Supine pulse rate: 6 hours post Maraviroc dose	Supine pulse rate: 8 hours post Maraviroc dose	Supine pulse rate: 12 hours post Maraviroc dose	Standing pulse rate: 1.5 hours post Maraviroc dose	Standing pulse rate: 2 hours post Maraviroc dose	Standing pulse rate: 2.5 hours post Maraviroc dose	Standing pulse rate: 3 hours post Maraviroc dose	Standing pulse rate: 4 hours post Maraviroc dose	Standing pulse rate: 6 hours post Maraviroc dose	Standing pulse rate: 8 hours post Maraviroc dose	Standing pulse rate: 12 hours post Maraviroc dose
Maraviroc + Placebo (Treatment B)	60.61	60.69	58.00	57.53	58.16	65.94	63.55	67.80	78.45	78.34	77.22	75.34	75.92	87.17	79.34	80.59
Maraviroc + Vardenafil (Treatment A)	67.56	66.20	61.64	60.42	60.22	71.39	67.67	71.25	85.78	85.16	82.25	80.05	79.97	93.53	84.41	82.47

Intervention	mm Hg (Least Squares Mean)
	Supine Systolic BP: 1.5 hour post Maraviroc dose	Supine Diastolic BP: 1.5 hour post Maraviroc dose	Supine Systolic BP: 2 hour post Maraviroc dose	Supine Diastolic BP: 2 hour post Maraviroc dose	Supine Systolic BP: 2.5 hour post Maraviroc dose	Supine Diastolic BP: 2.5 hour post Maraviroc dose	Supine Systolic BP: 3 hour post Maraviroc dose	Supine Diastolic BP: 3 hour post Maraviroc dose	Supine Systolic BP: 4 hour post Maraviroc dose	Supine Diastolic BP: 4 hour post Maraviroc dose	Supine Systolic BP: 6 hour post Maraviroc dose	Supine Diastolic BP: 6 hour post Maraviroc dose	Supine Systolic BP: 8 hour post Maraviroc dose	Supine Diastolic BP: 8 hour post Maraviroc dose	Supine Systolic BP: 12 hour post Maraviroc dose	Supine Diastolic BP: 12 hour post Maraviroc dose	Standing Systolic BP: 1.5 hour post Maraviroc dose	Standing Diastolic BP 1.5 hour post Maraviroc dose	Standing Systolic BP: 2 hour post Maraviroc dose	Standing Diastolic BP: 2 hour post Maraviroc dose	Standing Systolic BP: 2.5 hour post Maraviroc dose	Standing Diastolic BP 2.5 hour post Maraviroc dose	Standing Systolic BP: 3 hour post Maraviroc dose	Standing Diastolic BP: 3 hour post Maraviroc dose	Standing Systolic BP: 4 hour post Maraviroc dose	Standing Diastolic BP: 4 hour post Maraviroc dose	Standing Systolic BP: 6 hour post Maraviroc dose	Standing Diastolic BP: 6 hour post Maraviroc dose	Standing Systolic BP: 8 hour post Maraviroc dose	Standing Diastolic BP: 8 hour post Maraviroc dose	Standing Systolic BP: 12 hour post Maraviroc dose	Standing Diastolic BP: 12 hour post Maraviroc dose
Maraviroc + Placebo (Treatment B)	119.47	69.99	118.44	69.27	119.55	70.80	116.16	69.05	117.97	69.24	118.75	66.52	120.83	68.85	124.75	70.27	125.18	78.74	125.40	80.69	121.32	78.94	121.37	77.38	121.40	78.38	120.59	76.77	123.90	77.32	128.65	80.91
Maraviroc + Vardenafil (Treatment A)	118.36	68.06	113.45	66.31	114.67	66.98	114.11	67.28	115.89	68.37	116.45	65.67	116.61	66.34	122.81	67.95	120.82	74.81	118.49	74.90	115.52	72.29	117.10	73.73	119.35	77.29	118.29	73.34	120.43	74.06	128.38	78.65

vardenafil dihydrochloride

Description

Cross-References

Synonyms (43)

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Research

Studies (713)

Study Types

Clinical Trials (78)

Trial Overview

Trial Outcomes

Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

Duration of Surgery

Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks

Change From Baseline in Volume at First Detectable Leakage at 6 Weeks

Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks

Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older

Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks

Change From Baseline in Volume at First Desire to Void at 6 Weeks

Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks

Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks

Change From Baseline in Average Number of Daily Micturitions at 6 Weeks

Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks

Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma

"Percentage of Subjects Achieving Back to Normal Erectile Function"

Change From Baseline in Confidence for Completion at 12 Weeks or LOCF

Change From Baseline in Ease With Erection at 12 Weeks or LOCF

Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF

Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF

Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF

Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF

Change From Baseline in Success of Erection Maintenance at 12 Weeks

Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma

Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks

Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks

Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks

Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks

Number of Sexual Attempts Till First Successful Attempt

Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale

Satisfaction With Medication at Week 12 or LOCF

Change in Percentage From Baseline in Success of Penetration at 12 Weeks

Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma

Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma

Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF

"Percentage of Subjects Achieving Back to Normal Erectile Function"

Change From Baseline in Ease With Erection at 12 Weeks or LOCF

Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF

Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)

Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF

Change From Baseline in Success of Erection Maintenance at 12 Weeks

Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks

Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks

Satisfaction With Medication at Week 12 or LOCF

Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks

Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks

Change From Baseline in Confidence for Completion at 12 Weeks or LOCF

Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks

Number of Sexual Attempts Till First Successful Attempt

Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale

Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)

Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8

Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8

Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8

Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8

Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))

"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"

Number of Subjects With Postural Hypotension

Postural Changes in Pulse Rate

Postural Changes in Systolic and Diastolic Blood Pressure

Standing and Supine Pulse Rate

Standing and Supine Systolic and Diastolic Blood Pressure (BP)

30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use

Related Drugs (192)