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Sildenafil Study

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Sildenafil Citrate is the generic name for the drug Viagra. The little blue pill is the most prescribed erectile dysfunction drug on the market. Typically the starting dose when taking Sildenafil to treat Erectile Dysfunction is 50mg. However, the dosage is usually gradually increased to 100mg to improve performance without producing additional side effects.

The causes of Erectile Dysfunction can be psychological as well as physical. Starting treatment on a lower dose and then needing to increase that dose to improve sexual performance may have a negative psychological impact. This, in turn, could prolong or worsen Erectile Dysfunction.

Pfizer established a clinical trial to ascertain whether gradually increasing the dosage was beneficial, as opposed to immediately starting on a higher dose of 100mg. The study assessed the effect a 50mg or 100mg starting dose has on sexual performance and anxiety about future sexual relations.

Methods

To be eligible to participate in the study, men had to score 25 or below on the International Index of Erectile Function test. They must also have only ever taken six or fewer PDE5 inhibitors and must not have taken any in the previous four weeks.

During the study, men were given eight weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo). After the initial eight weeks, the men moved on to open-label flexible-dose of Sildenafil (50 or 100 mg) for four weeks.

Main Outcome Measures

The study aims to measure how effective, tolerable and satisfying 50mg or 100mg doses of Sildenafil Citrate were concerning sexual performance and anxiety about sex. Pfizer assessed criteria through a questionnaire at the end of the DBPC trail. They performed the same assessment at the end of the open-label program.

Results

The study concluded that Sildenafil improved performance when compared to the placebo and as a result, reduced anxiety experienced before sex. At the end of the double-blind study, 56% of men taking the 100mg dose reported no anxiety about their next sexual encounter. Of the men, given the 50mg dose, only 36% reported no anxiety.

The results from the DBPC study showed a significantly larger percentage of men responded to the 100mg dose compared to the 50mg dose. The 100mg dose did not appear to cause a higher incidence of adverse effects.

Conclusions

From this study, we can conclude that Sildenafil taken in either 50 mg or 100 mg doses produces tangible results. When compared to those taking the placebo, men taking Sildenafil had reduced anxiety levels, better sexual performance and were more satisfied overall with the treatment they received for Erectile Dysfunction. A comparison of those taking the 100mg dose vs the 50mg dose also showed similar results. The 100mg group experienced less anxiety, had an improved sexual experience and were more satisfied with their treatment than those taking the 50mg dose.

This study could be used to support a starting dose of 100mg when using Sildenafil to treat Erectile Dysfunction. The overall benefits of improved sexual performance and reduced anxiety about the next sexual encounter support an increased initial dose.

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Sildenafil Study

Methods Main Outcome Measures Results Conclusions FAQS Related Articles Useful Guides Sildenafil Citrate is the generic name for the drug Viagra. The little blue pill is the most prescribed erectile dysfunction drug on the market. Typically the starting dose when taking Sildenafil to treat Erectile Dysfunction is 50mg. However, the dosage is usually gradually increased […]

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Useful Guides

Drug Information for Consumers | FDA