Primary outcomeMean· 0-42 Days
Testosterone Area Below Baseline Interval
| Group | Value (ng*days/mL) | Spread |
|---|---|---|
| Degarelix 16+16 mg | 21.0 | 19.1 |
| Degarelix 32 mg | 16.0 | 11.6 |
| Degarelix 32+32 mg | 54.6 | 25.7 |
| Degarelix 64 mg | 70.6 | 53.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataExplorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 52 participants (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Germany
- Start
- Oct 2007
- Primary completion
- Mar 2009
- Completion
- May 2009
- First posted
- 11 Sept 2007 (estimated)
- Last update posted
- 4 May 2015 (estimated)
- Conditions
- BPH
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2007200820092010
- Ph 2
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
NCT00527488Oct 2007 to May 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- DegarelixDrug
- DegarelixDrug
- DegarelixDrug
- DegarelixDrug
Arms4
Experimental
Degarelix 16+16 mg
Experimental
Degarelix 32 mg
Experimental
Degarelix 32+32 mg
Experimental
Degarelix 64 mg
Primary outcomes14
Outcomes the sponsor listed as primary.
Testosterone Area Below Baseline Interval
Time frame · 0-42 Days
Registry description
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
Registry description
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
Registry description
The lowest concentration of testosterone measured within the time frame
Time of Minimal Value of Testosterone (Tnadir)
Time frame · Day 0-42
Registry description
The time point when the lowest testosterone concentration was measured
Duration of Testosterone Concentration Below 0.5 ng/mL
Time frame · Day 0-42
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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 outcomes(3)
Pharmacokinetic Parameters of Degarelix: AUCt
Time frame · 0-42 Days
Registry description
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
Registry description
Cmax was determined for concentration measurements up to Day 42
Pharmacokinetic Parameters of Degarelix: Tmax
Time frame · Day 0-42
Registry description
The time for maximal concentration (tmax) was determined for data up to Day 42
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Day 0-42
Time of Testosterone Concentration Below Baseline Interval
| Group | Value (Days) | Spread |
|---|---|---|
| Degarelix 16+16 mg | 21.2 | 12.8 |
| Degarelix 32 mg | 13.2 | 9.3 |
| Degarelix 32+32 mg | 34.3 | 10.8 |
| Degarelix 64 mg | 34.0 | 11.7 |
Primary outcomeMean· Day 0-42
Minimal Value of Testosterone (Cnadir)
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Degarelix 16+16 mg | 1.4 | 0.5 |
| Degarelix 32 mg | 0.9 | 0.5 |
| Degarelix 32+32 mg | 0.4 | 0.3 |
| Degarelix 64 mg | 0.4 | 0.2 |
Primary outcomeMean· Day 0-42
Time of Minimal Value of Testosterone (Tnadir)
| Group | Value (Days) | Spread |
|---|---|---|
| Degarelix 16+16 mg | 1.1 | 0.6 |
| Degarelix 32 mg | 1.3 | 0.8 |
| Degarelix 32+32 mg | 4.3 | 5.3 |
| Degarelix 64 mg | 8.8 | 9.9 |
Primary outcomeMedian· Day 0-42
Duration of Testosterone Concentration Below 0.5 ng/mL
| Group | Value (Days) |
|---|---|
| Degarelix 16+16 mg | 0.0 |
| Degarelix 32 mg | 0.0 |
| Degarelix 32+32 mg | 1.4 |
| Degarelix 64 mg | 2.0 |
Primary outcomeNumber· Day 0-42
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
| Group | Value (participants) |
|---|---|
| Degarelix 16+16 mg | 0 |
| Degarelix 32 mg | 2 |
| Degarelix 32+32 mg | 5 |
| Degarelix 64 mg | 8 |
Primary outcomeNumber· Day 0-42
Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration
| Group | Value (participants) |
|---|---|
| Degarelix 16+16 mg | 0 |
| Degarelix 32 mg | 0 |
| Degarelix 32+32 mg | 0 |
| Degarelix 64 mg | 0 |
Secondary and other outcome results(1)
Secondary outcomeMean· 0-42 Days
Pharmacokinetic Parameters of Degarelix: AUCt
| Group | Value (ng*day/mL) | Spread |
|---|---|---|
| Degarelix 16+16 mg | 70.7 | 20.6 |
| Degarelix 32 mg | 86.9 | 26.9 |
| Degarelix 32+32 mg | 158 | 43.7 |
| Degarelix 64 mg | 176 | 47.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Degarelix 16+16 mgTwo doses of Degarelix 16 mg on Day 0 and Day 14 | – | 0 / 13 | 13 / 13 |
| Degarelix 32 mgA single dose of Degarelix 32 mg on Day 0 | – | 0 / 12 | 11 / 12 |
| Degarelix 32+32 mgTwo doses of Degarelix 32 mg on Day 0 and Day 14 | – | 1 / 12 | 12 / 12 |
| Degarelix 64 mgA single dose of Degarelix 64 mg on Day 0 | – | 1 / 13 | 13 / 13 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 55 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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).
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