Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004043

Trial Description

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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.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00004043
  •   2012/10/23
  •   2007/09/10
  •   no
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Secondary IDs

  •   2007-003578-24 
  •   NCT00527488  (ClinicalTrials.gov)
  •   FE200486 CS25  (Ferring Pharmaceuticals)
  •   2007-003578-24 
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Health Condition or Problem studied

  •   BPH
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Degarelix
  •   Drug: Degarelix
  •   Drug: Degarelix
  •   Drug: Degarelix
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- 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)
- 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
- Minimal Value of Testosterone (Cnadir); time frame: Day 0-42; The lowest concentration of testosterone measured within the time frame
- Time of Minimal Value of Testosterone (Tnadir); time frame: Day 0-42; The time point when the lowest testosterone concentration was measured
- 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
- 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; time frame: Day 0-42; The baseline interval concentration is 0.75 x baseline concentration
- Prostate Specific Antigen (PSA) Concentration; time frame: Day 0-42
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.

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Secondary Outcome

- 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
- Pharmacokinetic Parameters of Degarelix: Cmax; time frame: Day 0-42; Cmax was determined for concentration measurements up to Day 42
- Pharmacokinetic Parameters of Degarelix: Tmax; time frame: Day 0-42; The time for maximal concentration (tmax) was determined for data up to Day 42

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2007/10/31
  •   52
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Inclusion Criteria

  •   Male
  •   55   Years
  •   75   Years
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Additional 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.

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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).

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Addresses

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    • Ferring Pharmaceuticals
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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    • Ferring Pharmaceuticals
    • Clinical Development Support 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2009/05/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.