NCT00527488

Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• BPH

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2007-09-11
• Last updated: 2015-05-04
• Results posted: 2010-11-25

Locations

1 site across 1 country: Germany