Phase 2 N=52 Randomized Treatment

Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

BPH

Bottom Line

View on ClinicalTrials.gov: NCT00527488 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Nov 2010

Primary outcome: Primary: Testosterone Area Below Baseline Interval — 21.0; 16.0; 54.6; 70.6 ng*days/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Degarelix (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: Male
Sponsor: Ferring Pharmaceuticals
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Testosterone Area Below Baseline Interval	21.0; 16.0; 54.6; 70.6	—
PRIMARY Time of Testosterone Concentration Below Baseline Interval	21.2; 13.2; 34.3; 34.0	—
PRIMARY Minimal Value of Testosterone (Cnadir)	1.4; 0.9; 0.4; 0.4	—
PRIMARY Time of Minimal Value of Testosterone (Tnadir)	1.1; 1.3; 4.3; 8.8	—
PRIMARY Duration of Testosterone Concentration Below 0.5 ng/mL	0.0; 0.0; 1.4; 2.0	—
PRIMARY Number of Subjects With Testosterone Concentration ≤0.5 ng/mL	0; 2; 5; 8; 0; 0	—
PRIMARY Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration	0; 0; 0; 0; 11; 10	—
PRIMARY Prostate Specific Antigen (PSA) Concentration	3.9; 3.0; 2.8; 3.2; 3.7; 2.5	—
PRIMARY Prostate Volume	42.0; 48.7; 38.1; 38.9; 34.5; 34.8	—
PRIMARY Maximal Urinary Flow	10.0; 11.7; 9.7; 9.1; 10.1; 11.2	—
PRIMARY Post-void Residual Urine Volume	63.4; 60.7; 56.7; 91.3; 58.0; 45.2	—
PRIMARY International Prostate Specific Symptom (IPSS) Score	17.7; 22.3; 18.2; 21.8; 11.6; 9.1	—
PRIMARY IPSS Global Quality of Life	4.2; 3.8; 4.3; 4.7; 2.9; 1.8	—
PRIMARY Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction	6.6; 6.5; 5.8; 5.9; 6.8; 6.2	—
SECONDARY Pharmacokinetic Parameters of Degarelix: AUCt	70.7; 86.9; 158; 176	—
SECONDARY Pharmacokinetic Parameters of Degarelix: Cmax	4.5; 6.9; 9.6; 15.8	—
SECONDARY Pharmacokinetic Parameters of Degarelix: Tmax	1.0; 1.3; 1.1; 1.1	—

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.

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00527488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.