Successful FSD trial for Futura
Futura Medical, the AIM-quoted pharmaceutical drug and medical device group that develops innova-tive products for the sexual healthcare market, has completed the pilot stage of a clinical trial in healthy female volunteers at the internationally renowned Porterbrook Clinic in Sheffield.
Futura Medical, the AIM-quoted pharmaceutical drug and medical device group that develops innova-tive products for the sexual healthcare market, has completed the pilot stage of a clinical trial in healthy female volunteers at the internationally renowned Porterbrook Clinic in Sheffield.
Four Subjects completed a single-blind, placebo controlled trial, during which they received placebo as well as three different strength doses of the compound under development.
Two subjects demonstrated enhanced blood circulation on exposure to the compound. Of these, one responded to the two highest doses while the second responded to the highest dose. The pattern of these responses mimics exactly the blood flow changes in women during clitoral stimulation and sexual arousal. There were no corresponding responses by any of the subjects to placebo doses.
Application of the formulation to the subjects was found to be safe and well tolerated. There were no adverse events in any subject at any dose, nor clinically significant changes in blood pressure, haematology and biochemistry profiles.
In accordance with the original study protocol a further six subjects are now being recruited to support these early observations, as well as providing the opportunity to use higher dose levels to further increase response rates without compromising subject safety or tolerability
James Barder, chief executive of Futura, said: 'This pilot study demonstrates that local application of our compound can improve blood flow in a way that mimics the female physiological response during clitoral stimulation and sexual arousal. Increased lubrication caused by the compound could provide a therapeutic intervention for women with certain sexual problems such as low libido and/or poor lubrication. Furthermore, enhanced lubrication resulting from increased blood flow would reduce the risk of condom slippage and breakage during sexual intercourse.
'It is estimated that two out of every five women experience some form of sexual dysfunction during their lives and that approximately 2% of condoms slip off during intercourse increasing the risk of unwanted pregnancies and the transference of sexual transmitted infections.'