Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

NCT00527488 | Completed Phase 2 Results

• 2 other identifiers: FE200486 CS252007-003578-24
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

BPH

Keywords

Benign Prostate Hyperplasia; BPH; PK/PD; GnRH antagonist

Outcome Measures

Primary Outcomes (14)

• 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)

  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

  Day 0-42

• Minimal Value of Testosterone (Cnadir)

  The lowest concentration of testosterone measured within the time frame

  Day 0-42

• Time of Minimal Value of Testosterone (Tnadir)

  The time point when the lowest testosterone concentration was measured

  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

  Day 0-42

• 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

  The baseline interval concentration is 0.75 x baseline concentration

  Day 0-42

• Prostate Specific Antigen (PSA) Concentration

  Day 0-42

• Prostate Volume

  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.

  Day 0-42

• Maximal Urinary Flow

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

  Day 0-42

• Post-void Residual Urine Volume

  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.

  Day 0-42

• International Prostate Specific Symptom (IPSS) Score

  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).

  Day 0-42

• IPSS Global Quality of Life

  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.

  Day 0-42

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

  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.

  Day 0-42

Secondary Outcomes (3)

• Pharmacokinetic Parameters of Degarelix: AUCt

  0-42 Days

• Pharmacokinetic Parameters of Degarelix: Cmax

  Day 0-42

• Pharmacokinetic Parameters of Degarelix: Tmax

  Day 0-42

Study Arms (4)

Degarelix 16+16 mg

EXPERIMENTAL

Drug: Degarelix

Degarelix 32 mg

EXPERIMENTAL

Drug: Degarelix

Degarelix 32+32 mg

EXPERIMENTAL

Drug: Degarelix

Degarelix 64 mg

EXPERIMENTAL

Drug: Degarelix

Interventions

Degarelix DRUG

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

Degarelix 16+16 mg

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

CRS Clinical Research Services Monchengladback GmbH

Mönchengladbach, 41061, Germany

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 4, 2015
• Results First Posted: November 25, 2010

Record last verified: 2015-04

Locations

DE (1)