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A single-centre, open-label, randomised explorative pharmacokinetic/pharmacodynamic study of the gonadotropin-releasing hormone receptor antagonist degarelix (FE 200486) in patients with benign prosta...

Update Il y a 5 ans
Reference: EUCTR2007-003578-24

A single-centre, open-label, randomised explorative pharmacokinetic/pharmacodynamic study of the gonadotropin-releasing hormone receptor antagonist degarelix (FE 200486) in patients with benign prostatic hyperplasia

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Extract

To explore the pharmakokinetic/pharmacodynamic relationships at different doses of degarelix in benign prostatic hyperplasia (BPH) patients and to select doses and dosing regime for Phase II efficacy trials.

Inclusion criteria

  • Patients with Benign Prostata Hypertropia (BPH) who fulfil the following criteria: a prostate volume of more than 30 mL, maximal uroflow of 12 mL/s or less; International Prostate Symptom Score (IPSS) of 13 or more, a serum prostate specific antigen (PSA) value below 10 ng/mL and no evidence of prostate cancer will be included in the study

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