Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

NCT00947882

Lower Urinary Tract Symptoms (LUTS)

COMPLETED PHASE2

Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

NCT01454349

Benign Prostatic Hyperplasia

COMPLETED PHASE1/PHASE2

Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

NCT00663858

Benign Prostatic Hypertrophy

COMPLETED PHASE3

Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH)

NCT00743184

Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptoms (LUTS)

TERMINATED PHASE2

Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

NCT03297398

Benign Prostatic Hyperplasia

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BPH

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.

Intervention Type DRUG

Degarelix

One dose of 32 mg administered as a single administration will be evaluated for 42 days.

Intervention Type DRUG

Degarelix

Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.

Intervention Type DRUG

Degarelix

One dose of 64 mg administered as a single administration will be evaluated for 42 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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).

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No