Benign Prostatic HyperplasiaPhase 2NCT00657839
Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
A Phase 2 study testing Levitra (Vardenafil, BAY38-9456) in people with Benign Prostatic Hyperplasia, run by Bayer at 15 sites in Germany.
Trial summary
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID. Read more about this study
- Who is it for?
- Ages 45 to 64 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Levitra (Vardenafil, BAY38-9456)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 15 sitesGermany
- Study dates
- Oct 2005to Jun 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males 45 to 64 years of age
- Lower urinary tract symptoms > 6 months
- International Prostate Symptom Score > 12
Who cannot join
- Prostate Specific Antigen > 3 ng/ml
- Residual urine volume > 150 m
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
- Other exclusion criteria apply acc. to Summary of Product Characteristics
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Study site
Biberach, Baden-Württemberg / 277, 88400
Study site
Düsseldorf, Nordrhein-Westfalen / 296, 40210
Study site
Hamburg, Hamburg / 287, 20251
Study site
Hamburg, Hamburg / 287, 20354
Study site
Kiel, Schleswig-Holstein / 306, 24105
Study site
Leipzig, Sachsen / 313, 04105
Study site
Leverkusen, Nordrhein-Westfalen / 331, 51373
Study site
Marburg, Hessen / 307, 35039
Study site
Mülheim, Nordrhein-Westfalen / 481, 45468
Study site
München, Bayern / 280, 81925
Study site
Osnabrück, Niedersachsen / 293, 49076
Study site
Rosenheim, Bayern / 280, 83022
Study site
Starnberg, Bayern / 280, 82319
Study site
Tostedt, Niedersachsen / 292, 21255
Study site
Weiden, Bayern / 280, 92637
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Keywords
- Benign Prostate Hyperplasia, Vardenafil, Genital Disease, Male: Signs and symptoms of Benign Prostate Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia, Genital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
10 mg Vardenafil bid
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score and maximal urinary flow
Measured: 8 weeks
Secondary outcomes (3)
International Prostate Symptom Score, storing and voiding subscore
Measured: 8 weeks
IIEF-EF domains score
Measured: 8 weeks
Safety and tolerability
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startOct 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657839
- Sponsor's protocol ID
- 11863
- Other IDs
- EudraCT No. 2005-002796-32
- Status last verified
- Oct 2014
- First submitted
- 9 Apr 2008
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00657839
- Acronym / sponsor ID
- 11863
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostate Hyperplasia, Vardenafil, Genital Disease, Male: Signs and symptoms of Benign Prostate Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males 45 to 64 years of age
- Lower urinary tract symptoms > 6 months
- International Prostate Symptom Score > 12
Key exclusion criteria (5 listed)
- Prostate Specific Antigen > 3 ng/ml
- Residual urine volume > 150 m
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
- Other exclusion criteria apply acc. to Summary of Product Characteristics
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 |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456)10 mg Vardenafil bid | Drug | Arm 1 |
| PlaceboMatching placebo | Drug | Arm 2 |
Primary outcome
International Prostate Symptom Score and maximal urinary flow
Time frame: 8 weeks
3 secondary outcomes
International Prostate Symptom Score, storing and voiding subscore
Time frame: 8 weeks
IIEF-EF domains score
Time frame: 8 weeks
Safety and tolerability
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levitra (Vardenafil, BAY38-9456) in people with Benign Prostatic Hyperplasia, run by Bayer at 15 sites 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 3 inclusion and 5 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
International Prostate Symptom Score and maximal urinary flow (time frame: 8 weeks). 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 28 Oct 2014.