Third Phase Clinical Trial
Hanmi Pharmaceutical Co. announced on August 16 that the third clinical trial results of its “Gugutams,” a combined treatment for prostatic hypertrophy and erectile dysfunction, were released in the august issue of “Journal of Sexual Medicine,” an international peer-reviewed medical journal.
In the third phase of the clinical trial, 510 South Korea male patients who suffer from both benign prostate hyperplasia (BPH) and erectile dysfunction (ED) were divided into three groups. The control group of patients were injected tadalafil 5mg once a day for 12 weeks, while the other two groups of patients were injected tamsulosinHCl 0.2mg + tadalafil 5mg or tamsulosinHCl 0.4mg + tadalafil 5mg.
As a result, the group of patients which took a combined treatment with tamsulosinHCl 0.4mg saw their international prostate symptom score (IPSS) decrease about 27 percent compared to the control group and showed no inferiority in sexual health improvement. However, the group taking a combined treatment with tamsulosinHCl 0.2mg showed no statistical significance in terms of IPSS improvement compared to the control group.
Park Myung-hee, managing director of marketing at Hanmi Pharmaceutical, said, “The third phase clinical trial results of the Gugutams capsule were released in international scholastic society meetings, such as the International Society for Sexual Medicine (ISSM) and American Urological Association (AUA). With the latest publication in the international medical journal, the efficacy and safety of the product have been internationally recognized. We will continuously make an effort to expand various treatment options in the urology sector through an evidence-based marketing strategy.”