Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

Phase 2

Completed

• Conditions: BPH
• Interventions: Drug: Degarelix

• Registration Number: NCT00527488
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Study Start: 2007-10
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Disposition First Submitted: 2010-04-09
• Disposition First Submitted QC: 2010-04-09
• Disposition First Posted: 2010-04-12
• Results First Submitted: 2010-08-16
• Results First Submitted QC: 2010-10-27
• Results First Posted: 2010-11-25
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 64 mg	Degarelix	-
Degarelix 16+16 mg	Degarelix	-
Degarelix 32 mg	Degarelix	-
Degarelix 32+32 mg	Degarelix	-

Primary Outcome Measures

Name	Time	Method
Minimal Value of Testosterone (Cnadir)	Day 0-42	The lowest concentration of testosterone measured within the time frame
Time of Minimal Value of Testosterone (Tnadir)	Day 0-42	The time point when the lowest testosterone concentration was measured
Duration of Testosterone Concentration Below 0.5 ng/mL	Day 0-42	The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level
Testosterone Area Below Baseline Interval	0-42 Days	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 of Testosterone Concentration Below Baseline Interval	Day 0-42	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
Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction	Day 0-42	The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from 'No sexual activity' to 'Almost always to always'. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL	Day 0-42
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration	Day 0-42	The baseline interval concentration is 0.75 x baseline concentration
Prostate Specific Antigen (PSA) Concentration	Day 0-42
Prostate Volume	Day 0-42	The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.
Maximal Urinary Flow	Day 0-42	Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.
Post-void Residual Urine Volume	Day 0-42	The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.
International Prostate Specific Symptom (IPSS) Score	Day 0-42	The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).
IPSS Global Quality of Life	Day 0-42	Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from "delighted" to "terrible" or 0 to 6.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters of Degarelix: AUCt	0-42 Days	Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42
Pharmacokinetic Parameters of Degarelix: Cmax	Day 0-42	Cmax was determined for concentration measurements up to Day 42
Pharmacokinetic Parameters of Degarelix: Tmax	Day 0-42	The time for maximal concentration (tmax) was determined for data up to Day 42

Trial Locations

Locations (1)

CRS Clinical Research Services Monchengladback GmbH; 🇩🇪 Monchengladbach, Germany