Abstract | INTRODUCTION: AIM: To assess, besides the usual measures of efficacy, the quality of erection, satisfaction with the sexual experience, symptoms of depression, and overall confidence. METHODS: This 12-week double-blind, placebo-controlled flexible-dose study assessed patients from the general ED population. Patients underwent a 4-week treatment-free period before randomization to vardenafil or matching placebo. Initial dosage was vardenafil 10 mg for 4 weeks. At 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose switching was also optional for the last 4 weeks. This paper describes per-patient success in satisfaction with hardness of erection, satisfaction with overall sexual experience, effect on overall self-confidence, and an assessment of symptoms of depression using the Center for Epidemiologic Studies Depression Scale. RESULTS: Mean per-patient satisfaction rates with erection hardness increased after vardenafil treatment to 43%, 59%, and 63% at weeks 4, 8, and 12, respectively, compared to placebo with 10%, 21%, and 23% (all P < 0.005 vs. placebo). Vardenafil also improved mean per-patient overall satisfaction 50-65% over the 4-12 week study period compared with 17-28% for placebo (P < 0.005). Symptoms of depression were statistically significantly reduced compared to placebo (P = 0.02); the effect was observed particularly in patients who were depressed at baseline (P = 0.01). Significantly more patients in the vardenafil treatment group reported improved self-confidence than those who received placebo (P < 0.005). CONCLUSIONS: A flexible-dose regimen of vardenafil improved satisfaction rates, symptoms of depression, and self-confidence, providing patients with an effective ED therapy that contributes to overall improvements in sexual function and confidence.
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Authors | Dimitrios Hatzichristou, Beatrice Cuzin, Antonio Martin-Morales, Jacques Buvat, Hartmut Porst, Nicole Laferriere, Tiemol Jerg Bandel, Francesco Montorsi, Vardenafil Study Group |
Journal | The journal of sexual medicine
(J Sex Med)
Vol. 2
Issue 1
Pg. 109-16
(Jan 2005)
ISSN: 1743-6095 [Print] Netherlands |
PMID | 16422913
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Imidazoles
- Phosphodiesterase Inhibitors
- Piperazines
- Sulfones
- Triazines
- Vardenafil Dihydrochloride
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Topics |
- Analysis of Variance
- Depression
(prevention & control)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Erectile Dysfunction
(drug therapy)
- Humans
- Imidazoles
(pharmacology, therapeutic use)
- Logistic Models
- Male
- Middle Aged
- Patient Satisfaction
- Phosphodiesterase Inhibitors
(pharmacology, therapeutic use)
- Piperazines
(pharmacology, therapeutic use)
- Prospective Studies
- Self Concept
- Sulfones
(pharmacology, therapeutic use)
- Triazines
(pharmacology, therapeutic use)
- Vardenafil Dihydrochloride
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