Clinical trial NCT00527488: Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: BPH
Keywords: Benign Prostate Hyperplasia
BPH
PK/PD
GnRH antagonist
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-11
Enrollment: 52
Sex: MALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.
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).

Primary outcomes:
measure: Testosterone Area Below Baseline Interval
timeFrame: 0-42 Days
measure: Time of Testosterone Concentration Below Baseline Interval
timeFrame: Day 0-42
measure: Minimal Value of Testosterone (Cnadir)
timeFrame: Day 0-42
measure: Time of Minimal Value of Testosterone (Tnadir)
timeFrame: Day 0-42
measure: Duration of Testosterone Concentration Below 0.5 ng/mL
timeFrame: Day 0-42
measure: Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
timeFrame: Day 0-42
measure: Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
timeFrame: Day 0-42
measure: Prostate Specific Antigen (PSA) Concentration
timeFrame: Day 0-42
measure: Prostate Volume
timeFrame: Day 0-42
measure: Maximal Urinary Flow
timeFrame: Day 0-42
measure: Post-void Residual Urine Volume
timeFrame: Day 0-42
measure: International Prostate Specific Symptom (IPSS) Score
timeFrame: Day 0-42
measure: IPSS Global Quality of Life
timeFrame: Day 0-42
measure: Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction
timeFrame: Day 0-42
Secondary outcomes:
measure: Pharmacokinetic Parameters of Degarelix: AUCt
timeFrame: 0-42 Days
measure: Pharmacokinetic Parameters of Degarelix: Cmax
timeFrame: Day 0-42
measure: Pharmacokinetic Parameters of Degarelix: Tmax
timeFrame: Day 0-42
Other outcomes:
Locations:
city: Monchengladbach
country: Germany
facility: CRS Clinical Research Services Monchengladback GmbH
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: