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Study Results
Study Results.
About this update from Futura Medical Plc
[{"type":"text","content":"\n Futura Medical PLC\n21 November 2005\n\n\n\n\nFor immediate release 21 November 2005\n\n\n\n Futura Medical plc\n\n Announces preliminary results\n\n from MED2003/5 pharmacodynamic study\n\n\nFutura Medical plc (AIM: FUM), the pharmaceutical drug and medical device group\nthat develops innovative products for the sexual healthcare market, announces\nthe completion of the second of two clinical trials in healthy male volunteers\n(Subjects) to evaluate three novel formulations of its topical gel for the\ntreatment of erectile dysfunction (ED).\n\n\nFifteen healthy males have completed a placebo controlled, double-blind,\nrandomised study. Each Subject received four different doses of glyceryl\ntrinitrate (GTN) in gels that were applied directly to the penis. The gels have\nbeen designed to deliver GTN into the penile tissues more efficiently than\nprevious formulations.\n\n\nAs with the initial pharmacokinetic study, the results of which were announced\non 7 November 2005, an excellent safety profile was observed. Dose-dependent\nside effects, which were predominantly mild headaches resolving without the need\nfor treatment, were seen in fewer than 10% of all dosing events. No serious\nadverse events were recorded and no falls in blood pressure occurred in any of\nthe subjects at any GTN dose. As with the pharmacokinetic study, GTN doses up\nto 0.25mg were found to be safe and well tolerated.\n\n\nThe effects of GTN on penile blood flow were assessed during this study using\nDoppler ultrasound technology. Despite the lack of sexual stimulation, many\nSubjects displayed penile blood flow changes following GTN dosing which were\nconsistent with those seen during sexual arousal. In particular, the rate of\nblood flow into the penis, as recorded by the Peak Systolic Velocity (PSV),\ndemonstrated increases in most of the Subjects on application of drug relative\nto baseline and compared with placebo. For example, with the preferred\nformulation approximately 70% of Subjects showed a greater increase in PSV\nrelative to baseline compared with placebo, an outcome that was statistically\nsignificant.\n\n\nDr Paul Sidhu, a consultant radiologist at King's College Hospital, London, and\none of the leading experts in penile Doppler ultrasound, confirmed that the\nchanges recorded by Doppler ultrasound after exposure to the gels were\ncons...