Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

Ferring Pharmaceuticals52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

BPH

Interventions

DegarelixDRUG

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

DegarelixDRUG

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

DegarelixDRUG

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

Eligibility

Sex: MALEMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (1)

CRS Clinical Research Services Monchengladback GmbH

Mönchengladbach, Germany

Outcomes

Primary Outcomes

Testosterone Area Below Baseline Interval

The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)

Time frame: 0-42 Days

Time of Testosterone Concentration Below Baseline Interval

The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit

Time frame: Day 0-42

Minimal Value of Testosterone (Cnadir)

The lowest concentration of testosterone measured within the time frame

Time frame: Day 0-42

Time of Minimal Value of Testosterone (Tnadir)

The time point when the lowest testosterone concentration was measured

Time frame: Day 0-42

Duration of Testosterone Concentration Below 0.5 ng/mL

The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level

Time frame: Day 0-42

Number of Subjects With Testosterone Concentration ≤0.5 ng/mL

Time frame: Day 0-42

Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration

The baseline interval concentration is 0.75 x baseline concentration

Time frame: Day 0-42

Prostate Specific Antigen (PSA) Concentration

Time frame: Day 0-42

Data from ClinicalTrials.gov

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Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes