Erectile DysfunctionPhase 3NCT00631969
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
A Phase 3 study testing Vardenafil ODT (STAXYN, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 47 sites in 6 countries.
Trial summary
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Vardenafil ODT (STAXYN, BAY38-9456)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 47 sitesin 6 countries
- Study dates
- Apr 2008to Jan 2009
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males 18 years-of-age or older
- Stable, heterosexual relationship for at least 6 months
- A history of erectile dysfunction (ED) for at least 6 months
Who cannot join
- Any underlying cardiovascular condition, including unstable angina pectoris
- History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
- Uncontrolled atrial fibrillation / flutter at screening
- History of surgical prostatectomy for prostate cancer
- Hereditary degenerative retinal disorders
- History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
Show all 14Show fewer
- Presence of penile anatomical abnormalities
- Subjects who have been confirmed with phenylketonuria (PKU)
- Spinal cord injury
- Resting or postural hypotension or hypertension
- Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
- Use of any treatment for ED within 7 days of Visit 1
- History of congenital QT prolongation
- History of syncope within the last 6 months prior to entry into the study
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
South Africa11 sites
Study site
Cape Town, Western Cape, 7463
Study site
Cape Town, Western Cape, 7530
Study site
Centurion, Gauteng, 0140
Study site
Durban, KwaZulu-Natal, 4001
Study site
Durban, KwaZulu-Natal, 4037
Study site
Durban, KwaZulu-Natal, 4091
Study site
Johannesburg, Gauteng, 1818
Study site
Johannesburg, Gauteng, 2198
Study site
Krugersdorp, Gauteng, 1739
Study site
Pretoria, Gauteng, 0001
Study site
Pretoria, Gauteng, 0083
Germany10 sites
Study site
Bautzen, Saxony, 02625
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20354
Study site
Leipzig, Saxony, 04109
Study site
Meissen, Saxony, 01662
Study site
Mönchengladbach, North Rhine-Westphalia, 41063
Study site
Mülheim, North Rhine-Westphalia, 45468
Study site
München, Bavaria, 81925
Study site
Osnabrück, Lower Saxony, 49076
Study site
Weiden, Bavaria, 92637
Belgium7 sites
Study site
Antwerp, 2020
Study site
Bruxelles - Brussel, 1000
Study site
Bruxelles - Brussel, 1070
Study site
Bruxelles - Brussel, 1200
Study site
Genk, 3600
Study site
Ghent, 9000
Study site
Liège, 4000
France7 sites
Study site
Lille, 59000
Study site
Lyon, 69000
Study site
Lyon, 69437
Study site
Marseille, 13006
Study site
Marseille, 13009
Study site
Mont-de-Marsan, 40000
Study site
Paris, 75008
Netherlands6 sites
Study site
Arnhem, 6836 BH
Study site
Deurne, 5751 XJ
Study site
Leiden, 2316 ZL
Study site
Losser, 7581 BV
Study site
Maastricht, 6212 XN
Study site
Nijverdal, 7442 LS
Spain6 sites
Study site
Alicante, Alicante, 03010
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08034
Study site
San Cristóbal de La Laguna, La Laguna, 38320
Study site
Valencia, Valencia, 46010
Study site
Vigo, Vigo, 36211
About this study
Official title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
- Conditions
- Erectile Dysfunction
- Being tested
- Vardenafil ODT (STAXYN, BAY38-9456), Placebo
- Keywords
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vardenafil ODT (STAXYN, BAY38-9456)Drug
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
PlaceboDrug
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Experimental | Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. Receives: Drug: Vardenafil ODT (STAXYN, BAY38-9456) |
| Placebo | Placebo comparator | Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
Measured: from baseline up to 12 weeks
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Measured: from baseline up to 12 weeks of treatment
Change From Baseline in Success of Erection Maintenance at 12 Weeks
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
Measured: from baseline up to 12 weeks of treatment
Secondary outcomes (17)
Percentage of Subjects Achieving "Back to Normal" Erectile Function
Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
Measured: up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.
Measured: from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.
Measured: from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.
Measured: from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.
Measured: from baseline up to 12 weeks of treatment
Number of Sexual Attempts Till First Successful Attempt
Measured: up to 12 weeks of treatment
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Measured: from baseline up to 12 weeks
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Measured: from baseline up to 12 weeks
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Measured: from baseline up to 12 weeks
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Measured: from baseline up to 12 weeks
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Measured: from baseline up to 12 weeks
Satisfaction With Medication at Week 12 or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.
Measured: up to 12 weeks
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)
Measured: up to 12 weeks of treatment
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Measured: Visit 5 after 12 weeks of treatment
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Measured: Visit 5 after 12 weeks of treatment
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Measured: Visit 5 after 12 weeks of treatment
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Measured: Visit 5 after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631969
- Sponsor's protocol ID
- 12093
- Other IDs
- 2008-000536-40, 2008
- Status last verified
- Dec 2014
- First submitted
- 29 Feb 2008
- Last updated
- 30 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.
PubMed 21883954Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.
PubMed 20233275Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.
PubMed 20925442Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.
PubMed 20807322
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I
- ClinicalTrials.gov ID
- NCT00631969
- Acronym / sponsor ID
- 12093
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, Schering-Plough
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Posted 21 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Experimental | Drug: Vardenafil ODT (STAXYN, BAY38-9456)Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males 18 years-of-age or older
- Stable, heterosexual relationship for at least 6 months
- A history of erectile dysfunction (ED) for at least 6 months
Key exclusion criteria (14 listed)
- Any underlying cardiovascular condition, including unstable angina pectoris
- History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
- Uncontrolled atrial fibrillation / flutter at screening
- History of surgical prostatectomy for prostate cancer
- Hereditary degenerative retinal disorders
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 |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456)Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT) | Drug | Vardenafil ODT (STAXYN, BAY38-9456) |
| PlaceboSubjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet | Drug | Placebo |
Primary outcome
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
Time frame: from baseline up to 12 weeks
The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
Time frame: from baseline up to 12 weeks of treatment
Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Change From Baseline in Success of Erection Maintenance at 12 Weeks
Time frame: from baseline up to 12 weeks of treatment
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
17 secondary outcomes
Percentage of Subjects Achieving "Back to Normal" Erectile Function
Time frame: up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
Time frame: from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
Time frame: from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
Time frame: from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
Time frame: from baseline up to 12 weeks of treatment
Number of Sexual Attempts Till First Successful Attempt
Time frame: up to 12 weeks of treatment
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
Time frame: from baseline up to 12 weeks
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Time frame: from baseline up to 12 weeks
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Time frame: from baseline up to 12 weeks
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Time frame: from baseline up to 12 weeks
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Time frame: from baseline up to 12 weeks
Satisfaction With Medication at Week 12 or LOCF
Time frame: up to 12 weeks
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
Time frame: up to 12 weeks of treatment
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
Time frame: Visit 5 after 12 weeks of treatment
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
Time frame: Visit 5 after 12 weeks of treatment
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
Time frame: Visit 5 after 12 weeks of treatment
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
Time frame: Visit 5 after 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21883954Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.
- Results publication: PubMed 20233275Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.
- Results publication: PubMed 20925442Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.
- Results publication: PubMed 20807322Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.
- 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
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vardenafil ODT (STAXYN, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 47 sites in 6 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 3 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 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in South Africa, Germany, Belgium, France, Netherlands and 1 more country. 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?
Yes. Results are posted in the registry (first posted 21 Jan 2011). 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?
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF (time frame: from baseline up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00631969, which also lists 4 linked publications.
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 30 Dec 2014.