Women's sexual function improves when partners are administered vardenafil for erectile dysfunction

A prospective, randomized, double-blind, placebo-controlled trial

Irwin Goldstein, William A. Fisher, Michael Sand, Raymond C. Rosen, Martin Mollen, Gerald Brock, Gary Karlin, Peter Pommerville, Keith Bangerter, Tiemo Joerg Bandel, Leonard Derogatis

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)819-832
Number of pages14
JournalJournal of Sexual Medicine
Volume2
Issue number6
DOIs
StatePublished - Nov 2005

Fingerprint

Erectile Dysfunction
Placebos
Orgasm
Sexual Partners
Therapeutics
Outcome Assessment (Health Care)
Vardenafil Dihydrochloride
Lubrication
Arousal
Least-Squares Analysis
Quality of Life
Observation
Pharmacology

Keywords

  • Male Erectile Disorder
  • Oral Vasoactive Agents
  • Pharmacological Studies in Sexual Function

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynecology

Cite this

Women's sexual function improves when partners are administered vardenafil for erectile dysfunction : A prospective, randomized, double-blind, placebo-controlled trial. / Goldstein, Irwin; Fisher, William A.; Sand, Michael; Rosen, Raymond C.; Mollen, Martin; Brock, Gerald; Karlin, Gary; Pommerville, Peter; Bangerter, Keith; Bandel, Tiemo Joerg; Derogatis, Leonard.

In: Journal of Sexual Medicine, Vol. 2, No. 6, 11.2005, p. 819-832.

Research output: Contribution to journalArticle

Goldstein, Irwin ; Fisher, William A. ; Sand, Michael ; Rosen, Raymond C. ; Mollen, Martin ; Brock, Gerald ; Karlin, Gary ; Pommerville, Peter ; Bangerter, Keith ; Bandel, Tiemo Joerg ; Derogatis, Leonard. / Women's sexual function improves when partners are administered vardenafil for erectile dysfunction : A prospective, randomized, double-blind, placebo-controlled trial. In: Journal of Sexual Medicine. 2005 ; Vol. 2, No. 6. pp. 819-832.
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abstract = "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.",
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AU - Sand, Michael

AU - Rosen, Raymond C.

AU - Mollen, Martin

AU - Brock, Gerald

AU - Karlin, Gary

AU - Pommerville, Peter

AU - Bangerter, Keith

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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.

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