Verdenafil improves patient satisfaction with erection hardness, orgasmic function and overall sexual experience, while improving quality of life in men with erectile dysfunction

Craig Donatucci, Terry Taylor, Marc Thibonnier, Keith Bangerter, Marc Gittelman, Richard Casey, Randall P. Abele, Gerald L. Andriole, Stephen M. Auerbach, Jack Barkin, Winston Barzell, Donald Bergner, Stacy Childs, Selwyn Cohen, David O. Cook, Jeoffrey Deeths, Mostafa M. Elhilali, Pamela I. Ellsworth, Howard B. Epstein, Robert A. FeldmanLouis Fields, Roger Fincher, William Fitch, Jenelle E. Foote, Jeffrey Frankel, Harold A. Fuselier, Larry I. Gilderman, Evan Goldfischer, James E. Gottesman, Fred Govier, Michael Greenspan, Wayne J. Hellstrom, Charles B. Herring, Gary S. Karlin, Joel M. Kaufman, Robert J. Krane, John N. Krieger, Allan Lau, William A. Leitner, Joel Lilly, Jack Lubensky, Nizamuddin Maruf, Keith Matthews, Andrew McCullough, Kevin T. McVary, Arnold Melman, William B. Monnig, Craig Neiderberger, Harin Padma-Nathan, Allan B. Patrick, Jon Lee Peterson, Peter J. Pommerville, Gary V. Price, George Raad, Paul R. Sieber, Alan W. Skolnick, Christopher P. Steidle, Cecile Storrie, David Talley, Joseph J. Tepas, Timothy S. Truitt, Luc Valiquette, Alexander Vukasin, Mitchell Wiatrak, John Williams, Rafael Wurzel, Joseph Zadra

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

Purpose. The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED). Matetials and methods. In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire. Results. Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38%, 52%, 58% and 18%) and overall satisfaction (45%, 58%, 62% and 23%) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients' answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10%, 22%, 21% and 4%), flushing (5%, 10%, 13% and 0%), dyspepsia (1%, 4%, 6% and <1%), and rhinitis (9%, 14%, 17% and 5%). Most AEs were mild or moderate in severity and transient in nature. Conclusion. Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.

Original languageEnglish (US)
Pages (from-to)185-192
Number of pages8
JournalJournal of Sexual Medicine
Volume1
Issue number2
DOIs
StatePublished - Jan 1 2004
Externally publishedYes

Fingerprint

Hardness
Erectile Dysfunction
Patient Satisfaction
Quality of Life
Placebos
Vardenafil Dihydrochloride
Observation
Dyspepsia
Rhinitis
Headache
Maintenance
Safety

Keywords

  • Erectile dysfunction
  • IIEF domain scores
  • PDE5 inhibitor
  • Secondary efficacy Variables
  • Vardenafil

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

Cite this

Verdenafil improves patient satisfaction with erection hardness, orgasmic function and overall sexual experience, while improving quality of life in men with erectile dysfunction. / Donatucci, Craig; Taylor, Terry; Thibonnier, Marc; Bangerter, Keith; Gittelman, Marc; Casey, Richard; Abele, Randall P.; Andriole, Gerald L.; Auerbach, Stephen M.; Barkin, Jack; Barzell, Winston; Bergner, Donald; Childs, Stacy; Cohen, Selwyn; Cook, David O.; Deeths, Jeoffrey; Elhilali, Mostafa M.; Ellsworth, Pamela I.; Epstein, Howard B.; Feldman, Robert A.; Fields, Louis; Fincher, Roger; Fitch, William; Foote, Jenelle E.; Frankel, Jeffrey; Fuselier, Harold A.; Gilderman, Larry I.; Goldfischer, Evan; Gottesman, James E.; Govier, Fred; Greenspan, Michael; Hellstrom, Wayne J.; Herring, Charles B.; Karlin, Gary S.; Kaufman, Joel M.; Krane, Robert J.; Krieger, John N.; Lau, Allan; Leitner, William A.; Lilly, Joel; Lubensky, Jack; Maruf, Nizamuddin; Matthews, Keith; McCullough, Andrew; McVary, Kevin T.; Melman, Arnold; Monnig, William B.; Neiderberger, Craig; Padma-Nathan, Harin; Patrick, Allan B.; Peterson, Jon Lee; Pommerville, Peter J.; Price, Gary V.; Raad, George; Sieber, Paul R.; Skolnick, Alan W.; Steidle, Christopher P.; Storrie, Cecile; Talley, David; Tepas, Joseph J.; Truitt, Timothy S.; Valiquette, Luc; Vukasin, Alexander; Wiatrak, Mitchell; Williams, John; Wurzel, Rafael; Zadra, Joseph.

In: Journal of Sexual Medicine, Vol. 1, No. 2, 01.01.2004, p. 185-192.

Research output: Contribution to journalArticle

Donatucci, C, Taylor, T, Thibonnier, M, Bangerter, K, Gittelman, M, Casey, R, Abele, RP, Andriole, GL, Auerbach, SM, Barkin, J, Barzell, W, Bergner, D, Childs, S, Cohen, S, Cook, DO, Deeths, J, Elhilali, MM, Ellsworth, PI, Epstein, HB, Feldman, RA, Fields, L, Fincher, R, Fitch, W, Foote, JE, Frankel, J, Fuselier, HA, Gilderman, LI, Goldfischer, E, Gottesman, JE, Govier, F, Greenspan, M, Hellstrom, WJ, Herring, CB, Karlin, GS, Kaufman, JM, Krane, RJ, Krieger, JN, Lau, A, Leitner, WA, Lilly, J, Lubensky, J, Maruf, N, Matthews, K, McCullough, A, McVary, KT, Melman, A, Monnig, WB, Neiderberger, C, Padma-Nathan, H, Patrick, AB, Peterson, JL, Pommerville, PJ, Price, GV, Raad, G, Sieber, PR, Skolnick, AW, Steidle, CP, Storrie, C, Talley, D, Tepas, JJ, Truitt, TS, Valiquette, L, Vukasin, A, Wiatrak, M, Williams, J, Wurzel, R & Zadra, J 2004, 'Verdenafil improves patient satisfaction with erection hardness, orgasmic function and overall sexual experience, while improving quality of life in men with erectile dysfunction', Journal of Sexual Medicine, vol. 1, no. 2, pp. 185-192. https://doi.org/10.1111/j.1743-6109.2004.04027.x
Donatucci, Craig ; Taylor, Terry ; Thibonnier, Marc ; Bangerter, Keith ; Gittelman, Marc ; Casey, Richard ; Abele, Randall P. ; Andriole, Gerald L. ; Auerbach, Stephen M. ; Barkin, Jack ; Barzell, Winston ; Bergner, Donald ; Childs, Stacy ; Cohen, Selwyn ; Cook, David O. ; Deeths, Jeoffrey ; Elhilali, Mostafa M. ; Ellsworth, Pamela I. ; Epstein, Howard B. ; Feldman, Robert A. ; Fields, Louis ; Fincher, Roger ; Fitch, William ; Foote, Jenelle E. ; Frankel, Jeffrey ; Fuselier, Harold A. ; Gilderman, Larry I. ; Goldfischer, Evan ; Gottesman, James E. ; Govier, Fred ; Greenspan, Michael ; Hellstrom, Wayne J. ; Herring, Charles B. ; Karlin, Gary S. ; Kaufman, Joel M. ; Krane, Robert J. ; Krieger, John N. ; Lau, Allan ; Leitner, William A. ; Lilly, Joel ; Lubensky, Jack ; Maruf, Nizamuddin ; Matthews, Keith ; McCullough, Andrew ; McVary, Kevin T. ; Melman, Arnold ; Monnig, William B. ; Neiderberger, Craig ; Padma-Nathan, Harin ; Patrick, Allan B. ; Peterson, Jon Lee ; Pommerville, Peter J. ; Price, Gary V. ; Raad, George ; Sieber, Paul R. ; Skolnick, Alan W. ; Steidle, Christopher P. ; Storrie, Cecile ; Talley, David ; Tepas, Joseph J. ; Truitt, Timothy S. ; Valiquette, Luc ; Vukasin, Alexander ; Wiatrak, Mitchell ; Williams, John ; Wurzel, Rafael ; Zadra, Joseph. / Verdenafil improves patient satisfaction with erection hardness, orgasmic function and overall sexual experience, while improving quality of life in men with erectile dysfunction. In: Journal of Sexual Medicine. 2004 ; Vol. 1, No. 2. pp. 185-192.
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title = "Verdenafil improves patient satisfaction with erection hardness, orgasmic function and overall sexual experience, while improving quality of life in men with erectile dysfunction",
abstract = "Purpose. The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED). Matetials and methods. In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire. Results. Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38{\%}, 52{\%}, 58{\%} and 18{\%}) and overall satisfaction (45{\%}, 58{\%}, 62{\%} and 23{\%}) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients' answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10{\%}, 22{\%}, 21{\%} and 4{\%}), flushing (5{\%}, 10{\%}, 13{\%} and 0{\%}), dyspepsia (1{\%}, 4{\%}, 6{\%} and <1{\%}), and rhinitis (9{\%}, 14{\%}, 17{\%} and 5{\%}). Most AEs were mild or moderate in severity and transient in nature. Conclusion. Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.",
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author = "Craig Donatucci and Terry Taylor and Marc Thibonnier and Keith Bangerter and Marc Gittelman and Richard Casey and Abele, {Randall P.} and Andriole, {Gerald L.} and Auerbach, {Stephen M.} and Jack Barkin and Winston Barzell and Donald Bergner and Stacy Childs and Selwyn Cohen and Cook, {David O.} and Jeoffrey Deeths and Elhilali, {Mostafa M.} and Ellsworth, {Pamela I.} and Epstein, {Howard B.} and Feldman, {Robert A.} and Louis Fields and Roger Fincher and William Fitch and Foote, {Jenelle E.} and Jeffrey Frankel and Fuselier, {Harold A.} and Gilderman, {Larry I.} and Evan Goldfischer and Gottesman, {James E.} and Fred Govier and Michael Greenspan and Hellstrom, {Wayne J.} and Herring, {Charles B.} and Karlin, {Gary S.} and Kaufman, {Joel M.} and Krane, {Robert J.} and Krieger, {John N.} and Allan Lau and Leitner, {William A.} and Joel Lilly and Jack Lubensky and Nizamuddin Maruf and Keith Matthews and Andrew McCullough and McVary, {Kevin T.} and Arnold Melman and Monnig, {William B.} and Craig Neiderberger and Harin Padma-Nathan and Patrick, {Allan B.} and Peterson, {Jon Lee} and Pommerville, {Peter J.} and Price, {Gary V.} and George Raad and Sieber, {Paul R.} and Skolnick, {Alan W.} and Steidle, {Christopher P.} and Cecile Storrie and David Talley and Tepas, {Joseph J.} and Truitt, {Timothy S.} and Luc Valiquette and Alexander Vukasin and Mitchell Wiatrak and John Williams and Rafael Wurzel and Joseph Zadra",
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TY - JOUR

T1 - Verdenafil improves patient satisfaction with erection hardness, orgasmic function and overall sexual experience, while improving quality of life in men with erectile dysfunction

AU - Donatucci, Craig

AU - Taylor, Terry

AU - Thibonnier, Marc

AU - Bangerter, Keith

AU - Gittelman, Marc

AU - Casey, Richard

AU - Abele, Randall P.

AU - Andriole, Gerald L.

AU - Auerbach, Stephen M.

AU - Barkin, Jack

AU - Barzell, Winston

AU - Bergner, Donald

AU - Childs, Stacy

AU - Cohen, Selwyn

AU - Cook, David O.

AU - Deeths, Jeoffrey

AU - Elhilali, Mostafa M.

AU - Ellsworth, Pamela I.

AU - Epstein, Howard B.

AU - Feldman, Robert A.

AU - Fields, Louis

AU - Fincher, Roger

AU - Fitch, William

AU - Foote, Jenelle E.

AU - Frankel, Jeffrey

AU - Fuselier, Harold A.

AU - Gilderman, Larry I.

AU - Goldfischer, Evan

AU - Gottesman, James E.

AU - Govier, Fred

AU - Greenspan, Michael

AU - Hellstrom, Wayne J.

AU - Herring, Charles B.

AU - Karlin, Gary S.

AU - Kaufman, Joel M.

AU - Krane, Robert J.

AU - Krieger, John N.

AU - Lau, Allan

AU - Leitner, William A.

AU - Lilly, Joel

AU - Lubensky, Jack

AU - Maruf, Nizamuddin

AU - Matthews, Keith

AU - McCullough, Andrew

AU - McVary, Kevin T.

AU - Melman, Arnold

AU - Monnig, William B.

AU - Neiderberger, Craig

AU - Padma-Nathan, Harin

AU - Patrick, Allan B.

AU - Peterson, Jon Lee

AU - Pommerville, Peter J.

AU - Price, Gary V.

AU - Raad, George

AU - Sieber, Paul R.

AU - Skolnick, Alan W.

AU - Steidle, Christopher P.

AU - Storrie, Cecile

AU - Talley, David

AU - Tepas, Joseph J.

AU - Truitt, Timothy S.

AU - Valiquette, Luc

AU - Vukasin, Alexander

AU - Wiatrak, Mitchell

AU - Williams, John

AU - Wurzel, Rafael

AU - Zadra, Joseph

PY - 2004/1/1

Y1 - 2004/1/1

N2 - Purpose. The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED). Matetials and methods. In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire. Results. Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38%, 52%, 58% and 18%) and overall satisfaction (45%, 58%, 62% and 23%) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients' answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10%, 22%, 21% and 4%), flushing (5%, 10%, 13% and 0%), dyspepsia (1%, 4%, 6% and <1%), and rhinitis (9%, 14%, 17% and 5%). Most AEs were mild or moderate in severity and transient in nature. Conclusion. Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.

AB - Purpose. The North American Pivotal Trial was designed to investigate the efficacy and safety of vardenafil in males with erectile dysfunction (ED). Matetials and methods. In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month study, vardenafil at three doses (5 mg, 10 mg, and 20 mg) was compared to placebo with the primary efficacy variables being the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score and per patient diary response success rates for penetration and maintenance of erection through completion of intercourse. Additional efficacy variables included IIEF domain scores measuring intercourse satisfaction, orgasmic function, sexual desire, and overall satisfaction. Diary entries for overall per patient satisfaction rates for hardness and sexual experience were also measured. Improvements in quality of sexual life were assessed using the Fugl-Meyer quality of life (QoL) questionnaire. Results. Compared to placebo, patients taking 10 mg and 20 mg doses of vardenafil showed statistically significantly greater improvement in IIEF domain scores measuring intercourse satisfaction (10.3 and 10.3 vs. 7.7), orgasmic function (7.1 and 6.9 vs. 5.3), overall satisfaction. (7.1 and 7.1 vs. 5.2) for vardenafil 10 mg and 20 mg vs. placebo, respectively, at last observation carried forward (LOCF). Vardenafil 5 mg was statistically significantly better than placebo for the secondary IIEF domain variables of intercourse satisfaction (8.9 vs. 7.7) and overall satisfaction (6.3 vs. 5.2) for vardenafil vs. placebo, respectively, at LOCF. Per patient satisfaction rates for the secondary diary variables measuring erection hardness (38%, 52%, 58% and 18%) and overall satisfaction (45%, 58%, 62% and 23%) were dose dependent and statistically significantly superior for vardenafil at 5 mg, 10 mg and 20 mg compared with placebo, respectively. Patients' answers to the Fugl-Meyer QoL questionnaire assessing improvement in sexual life also indicated statistically significant superiority for all doses of vardenafil vs. placebo treatment. The most frequent adverse events (AE) in the 5 mg, 10 mg, and 20 mg of vardenafil and placebo groups, respectively, were: headache (10%, 22%, 21% and 4%), flushing (5%, 10%, 13% and 0%), dyspepsia (1%, 4%, 6% and <1%), and rhinitis (9%, 14%, 17% and 5%). Most AEs were mild or moderate in severity and transient in nature. Conclusion. Vardenafil was superior to placebo for IIEF domain scores, per patient success rates for diary questions, and assessment of quality of sexual life, in a broad range of patients with ED irrespective of etiology or severity. Vardenafil was generally well tolerated, with most AEs being mild or moderate in severity and transient in nature.

KW - Erectile dysfunction

KW - IIEF domain scores

KW - PDE5 inhibitor

KW - Secondary efficacy Variables

KW - Vardenafil

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U2 - 10.1111/j.1743-6109.2004.04027.x

DO - 10.1111/j.1743-6109.2004.04027.x

M3 - Article

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AN - SCOPUS:20144369749

VL - 1

SP - 185

EP - 192

JO - Journal of Sexual Medicine

JF - Journal of Sexual Medicine

SN - 1743-6095

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