Erectile DysfunctionPhase 3NCT00492635
Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction and Sexual Dysfunction, Physiological, run by Bayer at 86 sites in 15 countries.
Trial summary
A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Erectile Dysfunction, Sexual Dysfunction, Physiological
- What is being tested?
- Levitra (Vardenafil, BAY38-9456)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 628 participants
- Where
- 86 sitesin 15 countries
- Study dates
- Dec 2004to Sep 2007
- Phase
- Phase 3
- 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 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- At Screening
- Males 18-64 years of age
- Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice
- Surgery scheduled within about 1 month of screening (Visit 1)
- Expressed an interest in resuming sexual activity as soon as possible after prostatectomy
- Heterosexual relationship
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- No pre-operative erectile dysfunction:
- International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening without any therapy/devices for improvement of erections
- No perforation of the prostate capsule by tumor
- At Randomization:
- Before being randomized subjects must still be meeting all Screening Inclusion Criteria, as well as the following criteria:
- bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report
- BNSRRP occurred within approximately 1 month post screening (Visit 1)
- No perforation of the prostate capsule by tumor:
- No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery
Who cannot join
- Subjects who are taking nitrates or nitric oxide donors
- Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin
- Known hypersensitivity to Vardenafil
- Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
- History of retinitis pigmentosa
- Unstable angina pectoris
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- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Severe chronic or acute liver disease
- Symptomatic postural hypotension in the past 6 months
- NYHA Class III or IV heart failure
- Life expectancy <3 years
- Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h)
- Anti-androgens use
- Residual prostate cancer, or requirement for radiotherapy or ADT after surgery
Trial locations and contacts
86 sites in 15 countries.
86 sites in 15 countries
Germany12 sites
Study site
Braunschweig, Lower Saxony, 38118
Study site
Dortmund, North Rhine-Westphalia, 44137
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Herne, North Rhine-Westphalia, 44627
Study site
Leverkusen, North Rhine-Westphalia, 51375
Study site
Mannheim, Baden-Wurttemberg, 68167
Study site
München, Bavaria, 81377
Study site
München, Bavaria, 81675
Study site
Offenbach, Hesse, 63069
Study site
Osnabrück, Lower Saxony, 49076
Study site
Tübingen, Baden-Wurttemberg, 72076
Study site
Weiden, Bavaria, 92637
United States11 sites
Study site
Cincinnati, Ohio, 45212-2787
Study site
Columbus, Ohio, 43214-1419
Study site
Des Moines, Iowa, 50309
Study site
Jackson, Mississippi, 39202
Study site
Jeffersonville, Indiana, 47130
Study site
Laguna Hills, California, 92653
Study site
Lancaster, Pennsylvania, 17604
Study site
Oklahoma City, Oklahoma, 73104
Study site
Poughkeepsie, New York, 12601
Study site
Providence, Rhode Island, 02904
Study site
Spokane, Washington, 99202
Canada10 sites
Study site
Barrie, Ontario, L4M 7G1
Study site
Calgary, Alberta, T2V 4R6
Study site
Chicoutimi, Quebec, G7H 4A3
Study site
Edmonton, Alberta, T6G 2C8
Study site
Fleurimont, Quebec, J1H 5N4
Study site
London, Ontario, N6A 4V2
Study site
Oakville, Ontario, L6H 3P1
Study site
St. John's, E2L 3J8
Study site
Toronto, Ontario, M4N 3M5
Study site
Victoria, V8R 6T9
Italy7 sites
Study site
Bari, 70124
Study site
Florence, 50139
Study site
Genova, 16132
Study site
Milan, 20127
Study site
Milan, 20132
Study site
Naples, 80131
Study site
Trieste, 34149
Spain7 sites
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08036
Study site
Madrid, Madrid, 28046
Study site
Málaga, Málaga, 29010
Study site
Valencia, Valencia, 46009
Study site
Valencia, Valencia, 46026
Study site
Vigo, Pontevedra, 36211
Belgium6 sites
Study site
Bruxelles - Brussel, 1000
Study site
Bruxelles - Brussel, 1200
Study site
Edegem, 2650
Study site
Hasselt, 3500
Study site
Leuven, 3000
Study site
Liège, 4000
Sweden6 sites
Study site
Gothenburg, 413 45
Study site
Gothenburg, 417 17
Study site
Halmstad, 301 85
Study site
Lund, 221 85
Study site
Skövde, 541 30
Study site
Västerås, 721 89
United Kingdom6 sites
Study site
Bath, Avon, BA1 3NG
Study site
Bristol, Avon, BS10 5NB
Study site
London, London, W6 8RF
Study site
Manchester, Manchester, M20 4BX
Study site
Slough, Berkshire, SL2 4HL
Study site
Taunton, Somerset, TA1 5DA
France5 sites
Study site
Carpentras, 84200
Study site
Lille, 59037
Study site
Lyon, 69437
Study site
Nîmes, 30000
Study site
Saint-Genis-Laval, 69230
South Africa5 sites
Study site
Cape Town, Western Cape, 7505
Study site
Cape Town, Western Cape, 8001
Study site
Johannesburg, Gauteng, 2193
Study site
Pietermaritzburg, KwaZulu-Natal, 3200
Study site
Pretoria, Gauteng, 0083
Finland3 sites
Study site
Oulu, 90220
Study site
Oulu, FI-90100
Study site
Tampere, 33100
Netherlands3 sites
Study site
Leiden, 2333 ZA
Study site
Nijmegen, 6525 GA
Study site
Rotterdam, 3015 GD
Austria2 sites
Study site
Graz, Styria, 8036
Study site
Salzburg, State of Salzburg, 5020
About this study
Official title: A Randomized, Double-blind, Double-dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving Erectile Function
A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Levitra (Vardenafil, BAY38-9456)Drug
9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
PlaceboDrug
9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether early, NIGHTLY dosing with vardenafil Significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placebo
Measured: 9 months
Secondary outcomes (1)
Assess whether early dosing of either NIGHTLY or PRN vardenafil over 9 months, followed by 2 months of withdrawal, increases efficacy of subsequent PRN use significantly better than placebo
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startDec 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 628 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
- NCT00492635
- Sponsor's protocol ID
- 11336
- Other IDs
- 2004-002172-42, 2004
- Status last verified
- Oct 2014
- First submitted
- 26 Jun 2007
- Last updated
- 28 Oct 2014
- Results posted
- 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, Double-dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving Erectile Function
- ClinicalTrials.gov ID
- NCT00492635
- Acronym / sponsor ID
- 11336
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Jun 2007 (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.
A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- At Screening
- Males 18-64 years of age
- Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice
- Surgery scheduled within about 1 month of screening (Visit 1)
- Expressed an interest in resuming sexual activity as soon as possible after prostatectomy
Key exclusion criteria (14 listed)
- Subjects who are taking nitrates or nitric oxide donors
- Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin
- Known hypersensitivity to Vardenafil
- Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
- History of retinitis pigmentosa
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)9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication | Drug | Arm 1 |
| Levitra (Vardenafil, BAY38-9456)9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication | Drug | Arm 2 |
| Placebo9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication | Drug | Arm 3 |
Primary outcome
Determine whether early, NIGHTLY dosing with vardenafil Significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placebo
Time frame: 9 months
1 secondary outcome
Assess whether early dosing of either NIGHTLY or PRN vardenafil over 9 months, followed by 2 months of withdrawal, increases efficacy of subsequent PRN use significantly better than placebo
Time frame: 13 months
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 and search for information of Bayer products for 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
86 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction and Sexual Dysfunction, Physiological, run by Bayer at 86 sites in 15 countries.
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 15 inclusion and 14 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 86 sites in Germany, United States, Canada, Italy, Spain and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Determine whether early, NIGHTLY dosing with vardenafil Significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placebo (time frame: 9 months). 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.