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Comparison of extended-release sildenafil with standard sildenafil in a randomized placebo-controlled study

Clinical Trial Summary: Vildegra vs. Viagra

Introduction

Sildenafil citrate, commonly known as Viagra, is a popular treatment for erectile dysfunction (ED). However, it can cause side effects like headaches and heart problems. A new drug called Vildegra encapsulates sildenafil in a substance called hypromellose, allowing it to release the medication slowly. This means Vildegra can work longer—up to 13 hours compared to Viagra’s 4 hours—potentially reducing side effects.

Aim of the Study

The goal of this trial was to show that Vildegra 50 mg is just as effective as Viagra 50 mg, while also being easier on the body and safer to use.

Study Design

The study involved men aged 19-60 with ED. It was a triple-arm, crossover, placebo-controlled trial, meaning participants tried Vildegra, a placebo, and Viagra at different times. Each treatment phase lasted four weeks, with a washout period in between to clear the previous drug from their system.

Results

Here’s what we found:

  • Vildegra boosted sexual activity 1.6 times more than Viagra and 2.4 times more than the placebo.
  • Both Vildegra and Viagra showed similar improvements in sexual function, with no significant difference in the scores measured (IIEF-5 score).
  • The initial IIEF-5 scores were about 14 (for Vildegra) and 13.9 (for Viagra), improving to around 20 after one month.
  • Vildegra had 1.6 times fewer side effects compared to Viagra.
  • No negative impacts on overall health measures were observed at the end of the study.

Conclusion

Vildegra is as effective as Viagra but better tolerated, leading to more frequent use. This suggests a promising alternative for men experiencing ED.

Practical Applications

Based on these findings, clinics can:

  • Evaluate the use of Vildegra as a first-line treatment option for ED.
  • Monitor patient outcomes to ensure effectiveness and tolerability.
  • Consider the lower incidence of side effects as a significant advantage in treatment plans.

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