Skip to main content
OpenTrials
Completed

NCT Number: NCT00527488

Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

BPH Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

55 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

CRS Clinical Research Services Monchengladback GmbH

Mönchengladbach, 41061, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

  • Man, 55 to 75 years of age.
  • 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.
  • 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.
  • 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:

  • Previous surgery of the prostate.
  • Previous treatment with GnRH agonists or GnRH antagonists.
  • Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
  • 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).
  • 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).

Treatment and study plan

degarelix

Drug

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

Primary outcomes

  1. Testosterone Area Below Baseline Interval

    Time frame: 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)

  2. Time of Testosterone Concentration Below Baseline Interval

    Time frame: 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

  3. Minimal Value of Testosterone (Cnadir)

    Time frame: Day 0-42

    The lowest concentration of testosterone measured within the time frame

  4. Time of Minimal Value of Testosterone (Tnadir)

    Time frame: Day 0-42

    The time point when the lowest testosterone concentration was measured

  5. Duration of Testosterone Concentration Below 0.5 ng/mL

    Time frame: Day 0-42

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

  6. Number of Subjects With Testosterone Concentration ≤0.5 ng/mL

    Time frame: Day 0-42

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

    Time frame: Day 0-42

    The baseline interval concentration is 0.75 x baseline concentration

  8. Prostate Specific Antigen (PSA) Concentration

    Time frame: Day 0-42

  9. Prostate Volume

    Time frame: 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.

  10. Maximal Urinary Flow

    Time frame: Day 0-42

    Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.

  11. Post-void Residual Urine Volume

    Time frame: 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.

  12. International Prostate Specific Symptom (IPSS) Score

    Time frame: 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).

  13. IPSS Global Quality of Life

    Time frame: 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.

  14. Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction

    Time frame: 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.

Secondary outcomes

  1. Pharmacokinetic Parameters of Degarelix: AUCt

    Time frame: 0-42 Days

    Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42

  2. Pharmacokinetic Parameters of Degarelix: Cmax

    Time frame: Day 0-42

    Cmax was determined for concentration measurements up to Day 42

  3. Pharmacokinetic Parameters of Degarelix: Tmax

    Time frame: Day 0-42

    The time for maximal concentration (tmax) was determined for data up to Day 42

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2007
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.