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Clinical study according to global standards proved: A Bulgarian medicinal product is effective against erectile dysfunction

12 November 2014

The Bulgarian medicinal product containing extract of the Tribulus Terrestris herb is effective for treatment of impotence. This was demonstrated by a 16-week clinical study among Bulgarian males, conducted according to the highest global standards for investigation of erectile dysfunction.

This study is the largest representative trial in this country of an over-the-counter medicinal product against erectile dysfunction. It was accomplished at 10 leading endocrinology and urology clinics in Sofia, Pleven, Ruse, Varna and Lovech using the International Index of Erectile Function (IIEF) questionnaire that is considered to be a gold standard for assessment of impotence worldwide.

The study conducted has a high demonstrative level with regard to its design - randomised, double-blind and placebo-controlled. It involved 180 males with erectile dysfunction, and/or low libido. It meets completely the Good Clinical Practice /GCP/ for trials, as well as the standards for manufacture and distribution of medicinal products - GMP and GDP.

“Statistically significant difference between Tribestan and placebo indices following a 3-month treatment of patients with mild to moderate erectile dysfunction was found”, pointed Prof. Dr. Zdravko Kamenov who presented the clinical study results. This difference was present already after the first month of treatment and increased in the course of time. Results showed significant improvement in libido, orgasmic function and overall intercourse satisfaction.

No adverse drug reactions associated with the use of the Bulgarian Tribulus Terrestris were reported during the study. Blood pressure remained stable even in patients who took medicines for treatment of high blood pressure. There was no statistically significant difference in the rest laboratory tests that were followed up, which indicates that Tribulus Terrestris does not lead to hepatic and renal function impairment during treatment of impotence.

Erectile dysfunction is a common condition in males all over the world. It has a strong negative effect on the quality of life of patients and their partners. The high incidence of this condition is associated, to a great extent, with ageing, but also with the coexistence of other serious diseases as well. The way of life, including obesity, smoking, alcohol abuse and sedentary lifestyle has also influence on erectile dysfunction.

Tribestan is a plant product manufactured by Sopharma AD, which contains dry extract from the aerial part of the plant Tribulus terrestris (Caltrop). Tribestan is used for complex treatment of low libido, impotence, male infertility, in lipid metabolic disorders, for total cholesterol and low-density lipoprotein reduction. It is also used for relief of marked neurovegetative and neuropsychic manifestations in women with climacteric and postcastration syndrome (a condition after surgical removal of ovaries).