OBJECTIVETo assess the clinical efficacy and safety of the combined α1‐ and postsynaptic α2‐blocker GYKI‐16084 compared to placebo during a 28‐day active treatment of patients with benign prostatic hyperplasia (BPH).PATIENTS AND METHODSAfter a 28‐day placebo run‐in phase, 7.5 and 15 mg GYKI‐16084 or placebo were administered twice daily for 28 days to patients with BPH in a randomized single‐blind Phase II study. Efficacy was primarily determined by changes in the American Urological Association (AUA) symptom scores and maximum urinary flow (Qmax), while safety was assessed by orthostatic changes and adverse‐event profile. A simplified International Index of Erectile Function questionnaire was used to assess effects on erectile function.RESULTSData from 63 patients were evaluated; the decrease in the AUA score during the active phase was greater in the 15 mg group (−6.05, −32.7%) than in the placebo (−4.3, 22.7%) or 7.5 mg (−3.55, −19.5%) groups. Qmax improved in both active treatment groups (+3.3 and +2.16 mL for the 7.5 and 15 mg groups, respectively) compared to placebo (+1.29 mL). None of the drug‐related adverse events associated with selective α1‐blockers were reported.CONCLUSIONThe combined α1‐ and postsynaptically selective α2‐blocker GYKI‐16084 significantly improved the AUA symptom scores and increased Qmax in patients with BPH, without inducing any adverse reaction, orthostatic changes or erectile dysfunction.

14 Mar 1980·Die Medizinische Welt

[Mono or adjuvant therapy with uroflux in urinary tract infections].

Article

Author: Bach, D ; Schneeberger, W ; Büdenbender, D

15 Nov 1979·Fortschritte der Medizin

[Efficacy and tolerance of Uroflux, a bladder and kidney tea, in the treatment of urinary tract infections, especially in diabetes mellitus].

Article

Author: Haase, W ; Steger, W

In an open study the use of Uroflux tea and sugar coated tablets individually and in combination with chemotherapeutic or antibiotic therapy in 52 patients is described. Urine analysis showed improvement rates of 92 and 93 per cent respectively. A blind trial was carried out separately in diabetic patients over a period of 14 days in order to evaluate the effects on daily blood sugar levels of Uroflux tea against a comparative product. It was clearly shown, that the patients on Uroflux tea showed no changes in daily blood sugar profiles. Contrary to this is was noteworthy that blood sugar concentrations in patients receiving the comparative product were elevated in the morning before breakfast as well as one hour after the midday meal. There were no side effects observed with any of the Uroflux dosage forms; even patients complaining of "sensitive stomach" reported excellent tolerance.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Hyperplasia	Phase 2	HU	Ivax Drug Research Institute LLC	-
Prostatic Hyperplasia	Phase 2	-	Teva Pharmaceutical Industries Ltd.	-

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