Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

Ferring

Status and phase: Completed; Phase 2

Conditions: BPH

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527488

2007-003578-24 (EudraCT Number)

FE200486 CS25

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: Male

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 4 patient groups

Degarelix 16+16 mg

Experimental group

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 32 mg

Experimental group

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 32+32 mg

Experimental group

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Degarelix 64 mg

Experimental group

Treatment:

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix

Drug: Degarelix