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 - FE 200486 CS25

• Conditions: 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; MedDRA version: 9.1Level: LLTClassification code 10004447Term: Benign prostatic hypertrophy

• Registration Number: EUCTR2007-003578-24-DE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-07
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.A signed written informed consent before any study related activity is performed.
2.Man, 45 to 75 years of age.
3.Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an IPSS of 13 or more at screening. See Section 7.1.4 for a description of the assessments.
4.A 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.
5.Has a baseline testosterone level above 3 ng/mL at screening.
6.A Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 and a body weight between 50 kg and 120 kg.
7.Has negative serology for Human Immunodeficiency Virus (HIV) 1, HIV 2, hepatitis B surface antigen, and hepatitis C virus antibody.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 (see Appendix 4) within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
5.A clinically significant neurological, gastrointestinal, renal, hepatic cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder or any other condition including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
6.Diagnosed cancer within the last 10 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin.
7.Present or a history of severe allergy or anaphylactic reactions.
8.A history of hypersensitivity to or is hypersensitive to any component of the investigational medicinal product.
9.A significant acute illness within two weeks prior to screening.
10.Any clinically significant laboratory abnormalities, which in the judgement of the investigator would interfere with the patient’s participation in this study or evaluation of the study results. Liver transaminases must be within normal limits.
11.Treatment with any drug modifying the testosterone level (see Appendix 3) or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
12.Donation of more than 700 mL blood within the last 10 months before the start of study.
13.Has a mental incapacity or language barriers precluding adequate understanding, co-operation, and compliance.
14.Is considered by the Investigator unsuitable to participate in the study for any other reason.
15.Has received an investigational medicinal product within the last one month for single dose studies (otherwise three months) before entering the study or longer if judged by the investigator to possibly influence the outcome of the current study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified