Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

NCT00527488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-05-04

Study results available
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Summary

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.

Conditions

  • BPH

Interventions

DRUG

Degarelix

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

DRUG

Degarelix

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

DRUG

Degarelix

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

DRUG

Degarelix

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

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-03-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527488 on ClinicalTrials.gov