BPHPhase 2NCT00527488
Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
A Phase 2 study testing Degarelix in people with BPH, run by Ferring Pharmaceuticals at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years, men only
- Conditions the study is for
- BPH
- What is being tested?
- Degarelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical Research Services Monchengladback GmbH
Mönchengladbach, 41061
About this study
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.
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.
Read the 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.
- Conditions
- BPH
- Being tested
- Degarelix
- Keywords
- Benign Prostate Hyperplasia, BPH, PK/PD, GnRH antagonist
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
DegarelixDrug
One dose of 32 mg administered as a single administration will be evaluated for 42 days.
DegarelixDrug
Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
DegarelixDrug
One dose of 64 mg administered as a single administration will be evaluated for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix 16+16 mg | Experimental | Not described Receives: Drug: Degarelix |
| Degarelix 32 mg | Experimental | Not described Receives: Drug: Degarelix |
| Degarelix 32+32 mg | Experimental | Not described Receives: Drug: Degarelix |
| Degarelix 64 mg | Experimental | Not described Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Day 0-42
Minimal Value of Testosterone (Cnadir)
The lowest concentration of testosterone measured within the time frame
Measured: Day 0-42
Time of Minimal Value of Testosterone (Tnadir)
The time point when the lowest testosterone concentration was measured
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
Measured: Day 0-42
Number of Subjects With Testosterone Concentration ≤0.5 ng/mL
Measured: 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
Measured: Day 0-42
Prostate Specific Antigen (PSA) Concentration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 0-42
Secondary outcomes (3)
Pharmacokinetic Parameters of Degarelix: AUCt
Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42
Measured: 0-42 Days
Pharmacokinetic Parameters of Degarelix: Cmax
Cmax was determined for concentration measurements up to Day 42
Measured: Day 0-42
Pharmacokinetic Parameters of Degarelix: Tmax
The time for maximal concentration (tmax) was determined for data up to Day 42
Measured: Day 0-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527488
- Sponsor's protocol ID
- FE200486 CS25
- Other IDs
- 2007-003578-24
- Status last verified
- Apr 2015
- First submitted
- 10 Sep 2007
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00527488
- Acronym / sponsor ID
- FE200486 CS25
- Conditions
- BPH
- Keywords
- Benign Prostate Hyperplasia, BPH, PK/PD, GnRH antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Posted 25 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DegarelixTwo doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. | Drug | Degarelix 16+16 mg |
| DegarelixOne dose of 32 mg administered as a single administration will be evaluated for 42 days. | Drug | Degarelix 32 mg |
| DegarelixTwo doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. | Drug | Degarelix 32+32 mg |
| DegarelixOne dose of 64 mg administered as a single administration will be evaluated for 42 days. | Drug | Degarelix 64 mg |
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.
3 secondary outcomes
Pharmacokinetic Parameters of Degarelix: AUCt
Time frame: 0-42 Days
Pharmacokinetic Parameters of Degarelix: Cmax
Time frame: Day 0-42
Pharmacokinetic Parameters of Degarelix: Tmax
Time frame: Day 0-42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Degarelix in people with BPH, run by Ferring Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone Area Below Baseline Interval (time frame: 0-42 Days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.