TY - JOUR
T1 - Women's sexual function improves when partners are administered vardenafil for erectile dysfunction
T2 - A prospective, randomized, double-blind, placebo-controlled trial
AU - Goldstein, Irwin
AU - Fisher, William A.
AU - Sand, Michael
AU - Rosen, Raymond C.
AU - Mollen, Martin
AU - Brock, Gerald
AU - Karlin, Gary
AU - Pommerville, Peter
AU - Bangerter, Keith
AU - Bandel, Tiemo Joerg
AU - Derogatis, Leonard R.
N1 - Funding Information:
This study was funded by Bayer Corporation. The authors gratefully acknowledge the involvement of all the investigators who participated in this study: Randall Abele (Edmonton Prostate & Urological Center, Canada); Richard Casey (Fe/Male Health Centres, Canada); Peter Lau (St Paul's Hospital, Canada); Jay Lee (Prostate Cancer Institute, Canada); Jean Simard (Polyclinique Medicale Concorde Urologie, Canada); Russell Egerdie (Probity Medical Research/Urology Associates, Canada); G. Ken Jansz (Burlington Professional Center, Canada); Joseph Zadra (Male/Female Health & Research Center, Canada); Robert Weiss (Robert Wood Johnson Medical School, USA); Harin Padma‐Nathan (The Male Clinic, USA); Stephen Auerbach (California Professional Research, USA); William Moseley (San Diego Uro‐Research, USA); Sidney Rosenblatt (Radiant Research Irvine, USA); Charles Herring (New Hanover Medical Research Associates, USA); Franklin Chu (San Bernadino Urological Associates, USA); Jed Kaminetsky (University Urology Associates, USA); James Rhyne (The Lipid Center, USA); Margaret Drehobl (Scripps Clinic, USA); Selwyn Cohen (Clinical Research Consultants, USA); Darrell Carmen (Georgia Urology, USA); Myron Murdock (Greenbelt Medical Associates, USA); George Raad (Metrolina Medical Research Associates, USA); Roger Miller (Jacksonville Impotence Treatment Center, USA).
Funding Information:
Conflict of Interest: Drs. Goldstein, Fisher, Rosen, Mollen, Brock, Karlin, Pommerville, and Derogatis are investigators, speakers, and consultants for Bayer HealthCare. Drs. Bandel, Bangerter, and Sand are employees of Bayer HealthCare. The study was funded by Bayer HealthCare.
PY - 2005/11
Y1 - 2005/11
N2 - Introduction. There are limited data concerning the sexual function of women whose male partners receive pharmacological treatment for erectile dysfunction (ED). Aim. One objective of this research was to prospectively compare the efficacy of vardenafil vs. placebo administered to men with ED in improving men's and women partners' sexual function and satisfaction. Another goal was to assess the relationship of erectile function changes in men with ED receiving treatment with sexual function changes in women partners not directly receiving treatment. Methods. A randomized, double-blind, placebo-controlled, multi-institutional comparison of vardenafil vs. placebo was performed in 229 couples (treated man with ED >6 months and untreated woman partner). Co-primary outcomes for which this research was statistically powered were Sexual Encounter Profile (SEP3) (treated man with ED) and Sexual Life Quality Questionnaire (mSLQQ-QOL) (untreated woman partner). Main Outcome Measures. Erectile function changes in men with ED receiving vardenafil vs. placebo were compared at last observation carried forward (LOGE) in SEP3, International Index of Erectile Function (IIEF-EF) and Erection Quality Scale (EQS). Sexual function at LOCF in women partners was determined by mSLQQ-QOL and Female Sexual Function Index (FSFI). Results. Compared with placebo at LOCF, vardenafil significantly increased least square (LS) mean scores in: (i) overall per-treated male SEP3 success rate, IIEF-EF, and EQS; and (ii) mSLQQ-QOL, total FSFI and sexual desire, subjective arousal, lubrication, orgasm and satisfaction FSFI domains in untreated women partners. Treatment-related improvement in erectile function as assessed by IIEF-EF and EQS was correlated reliably with improvement in women partners' FSFI total and individual domain scores. Conclusions. Vardenafil is an effective ED treatment in men that also significantly improves sexual function/satisfaction in untreated women partners. Women partners' sexual function improvements relate significantly and consistently to treatment-related improvements in men's erectile function. ED management should emphasize both members of the couple.
AB - Introduction. There are limited data concerning the sexual function of women whose male partners receive pharmacological treatment for erectile dysfunction (ED). Aim. One objective of this research was to prospectively compare the efficacy of vardenafil vs. placebo administered to men with ED in improving men's and women partners' sexual function and satisfaction. Another goal was to assess the relationship of erectile function changes in men with ED receiving treatment with sexual function changes in women partners not directly receiving treatment. Methods. A randomized, double-blind, placebo-controlled, multi-institutional comparison of vardenafil vs. placebo was performed in 229 couples (treated man with ED >6 months and untreated woman partner). Co-primary outcomes for which this research was statistically powered were Sexual Encounter Profile (SEP3) (treated man with ED) and Sexual Life Quality Questionnaire (mSLQQ-QOL) (untreated woman partner). Main Outcome Measures. Erectile function changes in men with ED receiving vardenafil vs. placebo were compared at last observation carried forward (LOGE) in SEP3, International Index of Erectile Function (IIEF-EF) and Erection Quality Scale (EQS). Sexual function at LOCF in women partners was determined by mSLQQ-QOL and Female Sexual Function Index (FSFI). Results. Compared with placebo at LOCF, vardenafil significantly increased least square (LS) mean scores in: (i) overall per-treated male SEP3 success rate, IIEF-EF, and EQS; and (ii) mSLQQ-QOL, total FSFI and sexual desire, subjective arousal, lubrication, orgasm and satisfaction FSFI domains in untreated women partners. Treatment-related improvement in erectile function as assessed by IIEF-EF and EQS was correlated reliably with improvement in women partners' FSFI total and individual domain scores. Conclusions. Vardenafil is an effective ED treatment in men that also significantly improves sexual function/satisfaction in untreated women partners. Women partners' sexual function improvements relate significantly and consistently to treatment-related improvements in men's erectile function. ED management should emphasize both members of the couple.
KW - Male Erectile Disorder
KW - Oral Vasoactive Agents
KW - Pharmacological Studies in Sexual Function
UR - http://www.scopus.com/inward/record.url?scp=28444480621&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=28444480621&partnerID=8YFLogxK
U2 - 10.1111/j.1743-6109.2005.00147.x
DO - 10.1111/j.1743-6109.2005.00147.x
M3 - Article
C2 - 16422806
AN - SCOPUS:28444480621
SN - 1743-6095
VL - 2
SP - 819
EP - 832
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 6
ER -