Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00527488
First received: September 10, 2007
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
BPH
Drug: Degarelix
Phase 2

Ferring Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Testosterone Area Below Baseline Interval [ Time Frame: 0-42 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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

  • Minimal Value of Testosterone (Cnadir) [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    The lowest concentration of testosterone measured within the time frame

  • Time of Minimal Value of Testosterone (Tnadir) [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    The time point when the lowest testosterone concentration was measured

  • Duration of Testosterone Concentration Below 0.5 ng/mL [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level

  • Number of Subjects With Testosterone Concentration ≤0.5 ng/mL [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
  • Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    The baseline interval concentration is 0.75 x baseline concentration

  • Prostate Specific Antigen (PSA) Concentration [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
  • Prostate Volume [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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.

  • Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pharmacokinetic Parameters of Degarelix: AUCt [ Time Frame: 0-42 Days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    Cmax was determined for concentration measurements up to Day 42

  • Pharmacokinetic Parameters of Degarelix: Tmax [ Time Frame: Day 0-42 ] [ Designated as safety issue: No ]
    The time for maximal concentration (tmax) was determined for data up to Day 42


Enrollment: 52
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 16+16 mg Drug: Degarelix
Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
Experimental: Degarelix 32 mg Drug: Degarelix
One dose of 32 mg administered as a single administration will be evaluated for 42 days.
Experimental: Degarelix 32+32 mg Drug: Degarelix
Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
Experimental: Degarelix 64 mg Drug: Degarelix
One dose of 64 mg administered as a single administration will be evaluated for 42 days.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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. See Section 7.1.4 for a description of the assessments.
  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 (see Appendix 4) 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 (see Appendix 3) or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527488

Locations
Germany
CRS Clinical Research Services Monchengladback GmbH
Monchengladbach, Germany, 41061
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00527488     History of Changes
Other Study ID Numbers: FE200486 CS25, 2007-003578-24
Study First Received: September 10, 2007
Results First Received: August 16, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ferring Pharmaceuticals:
Benign Prostate Hyperplasia
BPH
PK/PD
GnRH antagonist

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014