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Generic clomid pills no prescription Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM: PLE), the specialist developer of products for the treatment and management of urological disorders, announces that its European Phase III double-blind placebo controlled study of PSD502 for the treatment of premature ejaculation (PE) has met its three co-primary endpoints of Intra-vaginal Ejaculation Latency Time (’IELT’) and Index of Premature Ejaculation (’IPE’; Ejaculatory Control and Sexual Satisfaction domains).
The successful European study is one of two pivotal Phase III studies running in parallel with identical protocols. The second Phase III study is being conducted in North America and is expected to complete in the first half of 2009. Once the results from the US Phase III study become available, data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
European and US Phase III Study Details
Each Phase III study is a multi-centre, randomised, double blind, placebo-controlled efficacy study and the programme is expected to recruit a total of 540 patients across the two studies. Patients are treated for a 12 week period with an optional open label phase of up to 9 months.
The European study was conducted with 300 randomised patients across 32 investigational centres in 4 countries across Europe. Of these, 265 patients also entered the optional 9 month open label study.
European Phase III Study Outcome
Initial analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints. The intravaginal ejaculation latency time (IELT) geometric mean for PSD502 was 4 minutes compared to 1 (one) minute in placebo (pgeneric ultram online buy | Buy generic cipro | Generic diflucan pills no prescription