Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
This exploratory study will be conducted open label in a single investigational clinical
 unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned
 to receive 4 different treatments with degarelix.
The present study aims at exploring the potential of the currently available formulation of
 degarelix to treat BPH with only a short transient lowering of the serum testosterone
 concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing
 regimens (32 and 64 mg administered either as a single administration or as two
 administrations separated by 14 days) will be evaluated for 42 days.
Inclusion Criteria:

 Each patient must comply with all of the following inclusion criteria to be allowed to be
 randomised into the study:

 1. Man, 55 to 75 years of age.

 2. Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of
 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at
 screening.

 3. A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of
 adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed,
 a period of 6 weeks should be allowed after the biopsy before the patient is enrolled
 into the study.

 4. Has a baseline testosterone level above 3 ng/mL at screening.

 Exclusion Criteria:

 Any patient meeting one or more of the following exclusion criteria will not be included
 into the study:

 1. Previous surgery of the prostate.

 2. Previous treatment with GnRH agonists or GnRH antagonists.

 3. Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride
 (Avodart®) within the past 12 months before the study.

 4. Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin,
 alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed
 at Screening part I).

 5. Treatment with any drug modifying the testosterone level or function within 12 weeks
 before Screening visit part II (or Part I, if IPSS is performed at Screening part I).