Effect of Sildenafil Citrate on mild erectile dysfunction: Tabled at the ESSM

Daily Press

LYON, France – 11/15/2009 – Men suffering from a mildly impaired case of erectile dysfunction can achieve immense benefits from a clinical treatment with sildenafil citrate. The results of the 8 week long double-blind placebo controlled and the open labelled clinical trial were tabled here at the 12th congregation of the European Society for Sexual Medicine.

Almost all of the 152 participants of this 8 week long open labelled trial reported better erections, with about two-thirds of them reporting a hard and rigid erection.

The trials were conducted in two phases. The first phase was a double-blind placebo controlled method while the second phase was open-labelled. At the beginning of the trials all the men were reported to be suffering from mild ED.

Mild ED is diagnosed as a condition in men with an erectile function score ranging between 22 and 25 on the EF (Erectile Function) parameters.

Besides the mild ED diagnosis, the participants were suffering from erectile problems for a minimum of 3 months.

The open-labelled phase of the trial was started with an initial dose of 50mg of sildenafil. This was then adjusted to 25 or 100mg based on the satisfaction parameters. The method used to evaluate the satisfaction level was EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction)

An EDITS score above 50 was classified as satisfactory while a score equal to or below 50 was classified as unsatisfactory.

The results showed that 93% of the participants reported an EDITS score above 50% and were satisfied with sildenafil as a treatment to their erectile dysfunction problem. The average EDITS score was a high 86 which clearly demonstrated a high level of satisfaction among the participants with sildenafil.

Furthermore, the average scores for each of the erectile function (EF) parameters showed a marked improvement at the end of the open-labelled phase compared to the scores at the end of the double-blind placebo controlled phase (P <=.001) .

The side effects reported were mostly mild with some moderate cases.

The trial lead specialist Dr.Carrier claimed it was the first study ever done to study the effects of sildenafil on mild erectile dysfunction. The overall satisfaction and improvement indexes showed sildenafil treatment had as clear an advantage for patients as for those with moderate to severe ED.

The study did not signup participants who had four or more doses of any PDE-5 inhibitors in the last 12 weeks or any single dose of these drugs in the last 4 weeks before commencement of the trials.

The trials were funded by Pfizer Inc.

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